510(k) · Cleared
ClearedPhilips Microdose
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Digital Mammography Sweden AB · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on Apr 19, 2012 as substantially equivalent to K110025 (Sectra Imtec AB, 2011) after an 83-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Apr 19, 2012
- Review
- 83 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P990066 (2000). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backP990066 GE Healthcare Senographe Full Field Digital Mammography SystemGE Healthcare · 2000 · Recalled
- 1 generation backK110025 Sectra Microdose MammographySectra Imtec AB · 2011
- This deviceK120255 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P990066 | GE Healthcare Senographe Full Field Digital Mammography System | GE Healthcare | 2000 | 4 |
| −1 | K110025 | Sectra Microdose Mammography | Sectra Imtec AB | 2011 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K110025 | Sectra Microdose MammographySummary page 2…Predicate device Device Classification Full Field Digital, System, X-ray, Name Mamnmographic 510(k) Number K110025 Device Name Sectra MicroDose Mammography Model [30 Applicant Sectra lm… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123995 | Microdose SI | 2013 | 1 |
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K123995 (Philips Digital Mammography Sweden AB, 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K110025.
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. 2012, 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 Philips MicroDose L30 is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer.
The Philips MicroDose 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/K120255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120255: Philips Microdose.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120255
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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