Full Field Digital, System, X-Ray, Mammographic
Software Pristina 8.3 - ISO file
1manufacturer
10catalogue numbers in this listing
10recalls on this code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Fujifilm Imaging System (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | GE Medical Systems, LLC, United States |
|---|---|
| FDA product code | MUE |
| Device type | Full Field Digital, System, X-Ray, Mammographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1715 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K162268 |
| Record published | 2019-05-23 |
| Record revised | 2023-10-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 80 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Handling environment temperature 15 to 30 °C; Storage environment temperature -40 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRISTINA 0.1 | In distribution | |
| PRISTINA 0.0 | In distribution | |
| PRISTINA 2.8.4 | In distribution | |
| PRISTINA 0.0A | In distribution | |
| PRISTINA 2.8 | In distribution | |
| Accelera V5 | In distribution | |
| PRISTINA 2.9 | In distribution | |
| M3-2 | In distribution | |
| PRISTINA 2.10 | In distribution | |
| PRISTINA 2.8.3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Selenia® Dimensions® | Hologic, Inc. | 47 |
| Selenia Ffdm | Hologic, Inc. | 29 |
| Senographe Pristina | GE Medical Systems, LLC | 10 |
| Directview CR Mammography Cassette with EHR-M Screen | Carestream Health, Inc. | 10 |
| Giotto Class | IMS Giotto SPA | 6 |
| Directview CR Mammography Cassette with EHR-M3 Screen | Carestream Health, Inc. | 5 |
| Giotto Image 3DL | I.M.S. Internazionale Medico Scientifica SRL | 5 |
| CR-IR 392 | Fujifilm Corporation | 3 |
| Giotto Image | IMS Giotto SPA | 3 |
| CR HD5.0 AEC Cassette | Agfa Healthcare Inc. | 3 |
| Directview CR Mammography Cassette with HR Screen | Carestream Health, Inc. | 3 |
| Carestream CR Mammography Cassette with SNP-M1 Screen | Carestream Health, Inc. | 3 |
Showing 12 of 103. All products under Full Field Digital, System, X-Ray, Mammographic
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2025-10-24 | Class II | Radiation Control for Health and Safety Act | Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j). | 1,818 (1,580 US; 238 OUS) | |
| GE Medical Systems SCS | 510(k) number | 2023-12-26 | Class II | Radiation Control for Health and Safety Act | X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements. | 180 units (60 US; 120 OUS) | |
| GE Medical Systems, LLC | 510(k) number | 2019-05-16 | Class II | Equipment maintenance | Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. | 82 | 2020-12-16 |
| GE Medical Systems, LLC | 510(k) number | 2019-05-16 | Class II | Equipment maintenance | Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. | 16 | 2020-12-16 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2013-01-14 | Class II | Radiation Control for Health and Safety Act | GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual CD of the Senographe Essential. | 49 installed in the US. | 2013-11-26 |
| 2011-10-17 | Not classified | Device Design | GE Healthcare has become aware of inaccurate measurements on GE magnified images provided by Senographe 2000D Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety. | 1060 | 2014-03-12 |
| 2011-09-22 | Not classified | Software design | GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS and Essential Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety. | 2113 | 2012-10-16 |
| 2011-09-22 | Not classified | Software design | GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS and Essential Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety. | 1344 | 2012-10-16 |
| 2011-01-19 | Not classified | Radiation Control for Health and Safety Act | During installation it was discovered that the duplicate of the 21 CFR 1010 Certification label for the X-ray Generator Cabinet was missing from the installation kits that allow installation of the Senographe Essential in a van (mobile unit | 14 | 2012-05-16 |
| 2010-07-20 | Not classified | Radiation Control for Health and Safety Act | It was noticed that 3 units received in Japan were missing the rating plate on the X-ray tube cover. There is a potential that other X-ray tube covers are missing the rating plate. | 112 total | 2012-05-16 |
| 2010-07-20 | Not classified | Radiation Control for Health and Safety Act | It was noticed that 3 units received in Japan were missing the rating plate on the X-ray tube cover. There is a potential that other X-ray tube covers are missing the rating plate. | 112 total | 2012-05-16 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P080018 | 2010-11-03 | KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY | Carestream Health, Inc. |
| P050014 | 2009-01-09 | FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE | Fujifilm Medical System U.S.A., Inc. |
| P990066 | 2007-08-01 | GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL | GE Healthcare GmbH |
| P030010 | 2004-08-20 | SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Siemens Medical Solution |
| P010017 | 2004-05-12 | SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. |
| P010025 | 2003-09-24 | SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. |
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.