Mammomat Inspiration
Ffdm
1manufacturer
1catalogue number
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 | Siemens Healthcare Limited, Canada |
|---|---|
| FDA product code | MUE |
| Device type | Full Field Digital, System, X-Ray, Mammographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1715 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K122286 |
| Record published | 2016-09-24 |
| Record revised | 2026-01-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10140000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Selenia® Dimensions® | Hologic, Inc. | 47 |
| Selenia Ffdm | Hologic, Inc. | 29 |
| Full Field Digital, System, X-Ray, Mammographic | GE Medical Systems, LLC | 10 |
| 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 |
Showing 12 of 103. All products under Full Field Digital, System, X-Ray, Mammographic
Recalls Naming This Product
7 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 |
|---|---|---|---|---|---|---|---|
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2025-10-24 | Class II | Component design/selection | There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. | 6 units (3 US, 3 OUS) | |
| Siemens Medical Solutions USA, Inc. | UDI-DI | 2025-10-24 | Class II | Component design/selection | There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. | 1 unit (OUS only) | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2017-01-11 | Class II | Software design | Software error | 55 units | 2017-11-29 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2014-10-28 | Class II | Use error | It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may | 3 | 2015-07-20 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2014-09-18 | Class II | Process control | The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety cir | 3 | 2015-02-24 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2014-04-25 | Class II | Device Design | There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury. | 5 | 2014-12-15 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2013-02-28 | Class II | Device Design | Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility | 3 | 2014-02-21 |
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.