Discovery
PET Columbia Image System Assembly, No Detectors Installed, Common Gantry, Manufacturing Make
4manufacturers in China registered for this device type
7catalogue numbers in this listing
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 | GE Medical Systems, L.L.C. |
|---|---|
| FDA product code | KPS |
| Device type | System, Tomography, Computed, Emission |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| 510(k) | K133657 |
| Record published | 2016-08-01 |
| Record revised | 2026-02-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PETCT 710 | In distribution | |
| MI Digital Ready | In distribution | |
| MI | In distribution | |
| MI | In distribution | |
| MI Digital Ready | In distribution | |
| PETCT 610 | In distribution | |
| IQ 2.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NeuroQ | Syntermed, Inc. | 11 |
| Emory Cardiac Toolbox | Syntermed, Inc. | 10 |
| 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 |
| Affinity | Hermes Medical Solutions, AB | 3 |
Showing 12 of 172. All products under System, Tomography, Computed, Emission
Recalls Naming This Product
11 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | UDI-DI | 2022-06-02 | Class II | Error in labeling | As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to ser | 24,843 tables | |
| GE Medical Systems, LLC | 510(k) number | 2019-02-12 | Class II | Radiation Control for Health and Safety Act | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | 1113 in total | |
| GE Medical Systems, LLC | 510(k) number | 2019-02-12 | Class II | Radiation Control for Health and Safety Act | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | 1113 in total | |
| GE Medical Systems, LLC | 510(k) number | 2019-02-12 | Class II | Radiation Control for Health and Safety Act | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | 1113 in total | |
| GE Medical Systems, LLC | 510(k) number | 2019-02-12 | Class II | Radiation Control for Health and Safety Act | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | 1113 in total | |
| GE Medical Systems, LLC | 510(k) number | 2018-05-24 | Class II | Component change control | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply). | 42 devices total | 2019-02-08 |
| GE Medical Systems, LLC | 510(k) number | 2018-05-24 | Class II | Component change control | DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply). | 42 units total | 2019-02-08 |
| GE Medical Systems, LLC | 510(k) number | 2018-05-24 | Class II | Component change control | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply). | 42 units total | 2019-02-08 |
| GE Medical Systems, LLC | 510(k) number | 2017-05-19 | Class II | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. | 10,884 | 2018-07-29 |
| GE Medical Systems, LLC | 510(k) number | 2017-05-19 | Class II | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. | 10,884 | 2018-07-29 |
| GE Medical Systems, LLC | 510(k) number | 2017-05-19 | Class II | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. | 10,884 | 2018-07-29 |
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.