Selenia Ffdm
29 catalogue numbers from ASY-06753, listed by Hologic, Inc., United States, under Full Field Digital, System, X-Ray, Mammographic. 1 manufacturer in China is registered for this product code.
1manufacturer
29catalogue numbers in this listing
2510(k) clearances naming this product code
5recalls 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 | Hologic, Inc., 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 | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | P010025 |
| Record published | 2017-03-30 |
| Record revised | 2024-08-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2018-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ASY-06753 | Withdrawn | |
| ASY-06754 | Withdrawn | |
| FAB-00752 | Withdrawn | |
| 4-000-0144 | Withdrawn | |
| 3-000-4617 | Withdrawn | |
| 4-000-0293 | Withdrawn | |
| FAB-00609 | Withdrawn | |
| 5-000-0073 | Withdrawn | |
| ASY-05468 | Withdrawn | |
| ASY-00676 | Withdrawn | |
| ASY-06755 | Withdrawn | |
| FAB-00608 | Withdrawn | |
| ASY-06758 | Withdrawn | |
| ASY-06717 | Withdrawn | |
| ASY-01366 | Withdrawn | |
| ASY-00834 | Withdrawn | |
| 5-000-0072 | Withdrawn | |
| ASY-01656 | Withdrawn | |
| ASY-07973 | Withdrawn | |
| ASY-01427 | Withdrawn | |
| 3-535-0012 | Withdrawn | |
| 4-000-0308 | Withdrawn | |
| ASY-06716 | Withdrawn | |
| 3-000-1528 | Withdrawn | |
| ASY-06714 | Withdrawn | |
| 3-535-0087 | Withdrawn | |
| FAB-00754 | Withdrawn | |
| FAB-00610 | Withdrawn | |
| ASY-06715 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Selenia® Dimensions® | Hologic, Inc. | 47 |
| 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254090 | 2026-09-02 |
| K123873 | 2013-01-29 |
Recalls
5 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 |
|---|---|---|---|---|---|
| 2026-04-08 | Class II | Device Design | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. | 4,305 units | |
| 2020-01-21 | Class II | Process control | The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems. | 72 | 2021-08-11 |
| 2018-12-06 | Class II | Software design | Calibration issue not possible to visualize contrast uptake in the subtracted mammography images | 337 units | 2020-04-24 |
| 2014-05-13 | Class II | Component change control | Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury | 11 units | 2014-08-18 |
| 2013-09-06 | Class II | Software design | Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images | 62 systems | 2013-12-13 |
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.