Biograph Advanced Workflow (B16)
Catalogue number 10249725, listed by Siemens Medical Solutions USA, Inc., United States, under System, Tomography, Computed, Emission. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
46510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Beijing (1), Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Neusoft Positron Medical Systems Co., Ltd. | Shen Yang | Liaoning | Manufacturer | 1 |
Record
| Listed by | Siemens Medical Solutions USA, Inc., United States |
|---|---|
| FDA product code | KPS |
| Device type | System, Tomography, Computed, Emission |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K141971 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 50 °C; Storage environment humidity 10 to 95 % RH; Handling environment humidity 10 to 95 % RH; Handling environment temperature -20 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10249725 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NeuroQ | Syntermed, Inc. | 11 |
| Emory Cardiac Toolbox | Syntermed, Inc. | 10 |
| Discovery | GE Medical Systems, L.L.C. | 7 |
| uMI | Shanghai United Imaging Healthcare Co., Ltd. | 7 |
| Brightonix | Brightonix Imaging Inc. | 6 |
| UltraSPECT | Ultraspect USA, LLC | 5 |
| Discovery | G E Medical Systems Israel Ltd. | 5 |
| Veriton CT | Spectrum Dynamics Medical Ltd. | 5 |
| Cardius 2 | Digirad Corp. | 4 |
| Encompass™ SRS Fibreplast™ System | Qfix | 4 |
| Veriton NM | Spectrum Dynamics Medical Ltd. | 3 |
| Cedars-Sinai Cardiac Suite | Cedars Sinai Medical Center | 3 |
Showing 12 of 172. All products under System, Tomography, Computed, Emission
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261315 | 2026-05-21 |
| K251561 | 2025-07-31 |
| K251671 | 2025-07-03 |
| K243186 | 2024-10-30 |
| K233677 | 2024-01-12 |
| K231833 | 2023-07-13 |
| K231102 | 2023-05-17 |
| K223547 | 2022-12-22 |
| K212604 | 2021-09-16 |
| K210557 | 2021-05-12 |
| K210262 | 2021-03-03 |
| K200474 | 2020-03-20 |
| K193248 | 2020-02-14 |
| K190900 | 2019-05-06 |
| K180811 | 2018-05-23 |
| K173578 | 2017-12-20 |
| K173023 | 2017-11-17 |
| K170904 | 2017-06-01 |
| K162483 | 2017-01-09 |
| K162736 | 2016-10-25 |
| K162337 | 2016-09-08 |
| K152880 | 2016-01-12 |
| K151486 | 2015-07-17 |
| K141971 | 2014-09-12 |
| K142006 | 2014-08-21 |
| K131634 | 2013-08-16 |
| K123737 | 2013-01-29 |
| K113448 | 2011-12-17 |
| K101550 | 2010-09-03 |
| K083852 | 2009-03-23 |
| K082506 | 2008-11-21 |
| K081453 | 2008-06-23 |
| K072567 | 2007-10-30 |
| K071068 | 2007-05-14 |
| K060631 | 2006-03-17 |
| K060060 | 2006-02-03 |
| K041166 | 2004-05-17 |
| K010137 | 2001-02-13 |
| K992731 | 1999-11-10 |
| K982387 | 1998-10-06 |
| K972360 | 1997-09-23 |
| K970627 | 1997-09-04 |
| K952109 | 1995-08-23 |
| K942145 | 1995-02-22 |
| K942146 | 1994-09-23 |
| K940236 | 1994-05-03 |
Recalls Naming This Product
37 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2017-02-20 | Class II | Labeling Change Control | The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. | 18 units | 2017-09-17 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2017-02-20 | Class II | Labeling Change Control | The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. | 6 units | 2017-09-17 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2017-02-20 | Class II | Labeling Change Control | The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. | 9 units | 2017-09-17 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2017-02-20 | Class II | Labeling Change Control | The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. | 4 units | 2017-09-17 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 83 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 36 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 5 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 48 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 46 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 1 unit | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 1 unit | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 102 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 15 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 16 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 49 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 2017-05-08 | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 2 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 4 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 2 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 9 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 28 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 3 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 9 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 12 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 25 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 2 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 13 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 143 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 5 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 47 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 100 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 51 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 127 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 22 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 4 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 2 units | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-04-22 | Class II | Nonconforming Material/Component | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. | 63 units | 2017-05-08 |
Recalls
29 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-07-12 | Class II | Device Design | During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leadin | 108 systems | |
| 2023-01-16 | Class II | Process control | This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. | 1 unit | |
| 2023-01-16 | Class II | Process control | This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. | 4 units | |
| 2023-01-16 | Class II | Process control | This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. | 6 units | |
| 2022-03-11 | Class II | Nonconforming Material/Component | There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue. | 7 devices | 2023-04-14 |
| 2020-08-14 | Class II | Device Design | This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential risk. | 412 units | 2023-05-01 |
| 2018-11-30 | Class II | Device Design | Improper design or specifications. | 171 | 2020-09-02 |
| 2018-10-05 | Class II | Other | The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A., | 264 units | 2021-02-11 |
| 2018-09-28 | Class II | Process control | The terminals on the plug may become loose and overheat. | 78 units | 2021-02-11 |
| 2018-09-28 | Class II | Process control | The terminals on the plug may become loose and overheat. | 890 units | 2021-02-11 |
| 2018-02-21 | Class II | Software design (manufacturing process) | Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement | 14 units | 2018-10-12 |
| 2017-11-07 | Class II | Software design | The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do n | 2 units | 2019-04-29 |
| 2017-11-07 | Class II | Software design | The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do n | 2 units | 2019-04-29 |
| 2017-09-18 | Class II | Equipment maintenance | The torque wrench used to tighten system bolts during installation was found to be out of tolerance | 16 devices | 2017-12-11 |
| 2016-12-13 | Class II | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | 1 unit | 2017-05-08 |
| 2016-12-13 | Class II | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | 34 units | 2017-05-08 |
| 2016-12-13 | Class II | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | 41 units | 2017-05-08 |
| 2016-12-13 | Class II | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | 102 units | 2017-05-08 |
| 2016-12-13 | Class II | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | 51 units | 2017-05-08 |
| 2016-12-13 | Class II | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | 71 units | 2017-05-08 |
| 2016-12-13 | Class II | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | 1 unit | 2017-05-08 |
| 2016-12-13 | Class II | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | 1 unit | 2017-05-08 |
| 2016-12-13 | Class II | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | 88 units | 2017-05-08 |
| 2016-12-13 | Class II | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | 1 unit | 2017-05-08 |
| 2016-12-13 | Class II | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. | 18 units | 2017-05-08 |
| 2016-04-25 | Class II | Process design | The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service. | 1 unit | 2017-02-01 |
| 2016-04-25 | Class II | Process design | The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service. | 2 units | 2017-02-01 |
| 2016-04-25 | Class II | Process design | The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service. | 1 unit | 2017-02-01 |
| 2016-04-25 | Class II | Process design | The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service. | 1 unit | 2017-02-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.