PMA · Approved
Recalled · Class II · 2026Lorad Digital Breast Imager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · MUE Full Field Digital, System, X-Ray, Mammographic
Approved on Mar 15, 2002 through premarket approval, which rests on the device’s own clinical evidence after a 319-day review. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 15, 2002
- Review
- 319 days
- Class
- Class II
- Product code
- MUE
- Recalls
- 4
5 later devices descend from it, 1 citing it directly.
- This deviceP010025 Lorad Digital Breast ImagerHologic, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK162670 RSM 1824C with RConsole1DRTECH Corporation · 2017
- Descendant · 2 generations on · 1 of its ownK202902 2430MCA with Xmaru WRayence Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK170930 RSM 2430CDRTECH Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK243849 2430TCA with Xmaru WRayence Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK241113 Vivix-MVieworks Co., Ltd. · 2025
Most influential descendants
Showing 5 of 5 · See all- K162670RSM 1824C with RConsole1DRTECH Corporation · 2017 · cites it directly4descendants
- K2029022430MCA with Xmaru WRayence Co., Ltd. · 2021 · 2 generations on1descendant
- K170930RSM 2430CDRTECH Corporation · 2017 · 2 generations on1descendant
- K2438492430TCA with Xmaru WRayence Co., Ltd. · 2025 · 3 generations on0descendants
- K241113Vivix-MVieworks Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P010025 | Lorad Digital Breast Imager | Hologic, Inc. | 2002 | — |
| +1 | K162670 | RSM 1824C with RConsole1 | DRTECH Corporation | 2017 | — |
| +2 | K202902 | 2430MCA with Xmaru W | Rayence Co., Ltd. | 2021 | — |
| +2 | K170930 | RSM 2430C | DRTECH Corporation | 2017 | — |
| +3 | K243849 | 2430TCA with Xmaru W | Rayence Co., Ltd. | 2025 | — |
| +3 | K241113 | Vivix-M | Vieworks Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUE device
- #1 K253678 MAMMOMAT B.brilliant (11372950)score 13.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162670 | RSM 1824C with RConsole1 | 2017 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2026 | Class II | Z-2167-2026 | Device Design | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. |
| May 13, 2014 | Class II | Z-1700-2014 | 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 |
| Sep 6, 2013 | Class II | Z-2301-2013 | Software design | Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images |
| Feb 28, 2008 | Not classified | Z-1546-2008 | Software design | Marker Misalignment: The new software version contained a magnification factor that shows CAD markers misaligned with the identified indications. The marked area is misaligned up to 2cm from the indication. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K162670 (DRTECH Corporation, 2017) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MUE devicesMUE Full Field Digital, System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUE
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUE
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUE
40in 2025
MAUDE reports naming product code MUE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | — | 0 | 0 |
| 2008 | 5 | — | 1 | 4 |
| 2009 | 8 | — | 1 | 3 |
| 2010 | 10 | — | 2 | 2 |
| 2011 | 10 | 192 | 5 | 10 |
| 2012 | 4 | 123 | 0 | 6 |
| 2013 | 7 | 207 | 0 | 11 |
| 2014 | 1 | — | 2 | 7 |
| 2015 | 1 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 19 |
| 2017 | 8 | 95 | 6 | 115 |
| 2018 | 2 | — | 1 | 145 |
| 2019 | 2 | — | 1 | 80 |
| 2020 | 4 | 188 | 0 | 49 |
| 2021 | 4 | 164 | 0 | 25 |
| 2022 | 3 | 404 | 0 | 36 |
| 2023 | 1 | — | 1 | 29 |
| 2024 | 1 | — | 0 | 33 |
| 2025 | 3 | 255 | 4 | 40 |
| 2026 | 4 | 185 | 1 | — |
https://510kreport.com/device/P010025 · printed Nov 5, 2026
Cite this page
510(k) Report. “P010025: Lorad Digital Breast Imager.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P010025
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026