510(k) · Cleared
ClearedSectra Microdose Mammography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sectra Imtec AB · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on Apr 28, 2011 as substantially equivalent to P050014 (Fujifilm Medical System U.S.A., Inc., 2006) and 1 other predicate after a 115-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Apr 28, 2011
- Review
- 115 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P990066 (2000). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP990066 GE Healthcare Senographe Full Field Digital Mammography SystemGE Healthcare · 2000 · Recalled
- This deviceK110025 Sectra Microdose MammographySectra Imtec AB · 2011
- Descendant · cites it directly · 2 of its ownK120255 Philips MicrodosePhilips Digital Mammography Sweden AB · 2012
- Descendant · cites it directly · 1 of its ownK123995 Microdose SIPhilips Digital Mammography Sweden AB · 2013
- Descendant · 2 generations on · 0 of its ownK130704 Microdose SIPhilips Digital Mammography Sweden AB · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P990066 | GE Healthcare Senographe Full Field Digital Mammography System | GE Healthcare | 2000 | 4 |
| 0 (this device) | K110025 | Sectra Microdose Mammography | Sectra Imtec AB | 2011 | — |
| +1 | K120255 | Philips Microdose | Philips Digital Mammography Sweden AB | 2012 | — |
| +1 | K123995 | Microdose SI | Philips Digital Mammography Sweden AB | 2013 | — |
| +2 | K130704 | Microdose SI | Philips Digital Mammography Sweden AB | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P050014 | Fuji's Computed Radiography Mammography Suite (Fcrms)Summary page 2…ystem FCRMS Software PMA Applicant FUJIFILM MEDICAL SYSTEM U.S.A., GE HEALTHCARE INC. PMA Number P050014 P990066 Product Code MUE MUE Advisory R… | 2006 |
| * | P990066 | GE Healthcare Senographe Full Field Digital Mammography SystemSummary page 2…ware PMA Applicant FUJIFILM MEDICAL SYSTEM U.S.A., GE HEALTHCARE INC. PMA Number P050014 P990066 Product Code MUE MUE Advisory Radiology R… | 2000 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2011, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Sectra MicroDose Mammography L30 is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer.
The Sectra MicroDose Mammography L30 is intended to be used in the same clinical applications as traditional film/screen systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110025 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110025: Sectra Microdose Mammography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110025
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026