510(k) · Cleared
ClearedMicrodose SI
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 Feb 1, 2013 as substantially equivalent to K110025 (Sectra Imtec AB, 2011) and 1 other predicate after a 37-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Feb 1, 2013
- Review
- 37 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P990066 (2000). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backP990066 GE Healthcare Senographe Full Field Digital Mammography SystemGE Healthcare · 2000 · Recalled
- 2 generations backK110025 Sectra Microdose MammographySectra Imtec AB · 2011
- 1 generation backK120255 Philips MicrodosePhilips Digital Mammography Sweden AB · 2012
- This deviceK123995 Microdose SIPhilips Digital Mammography Sweden AB · 2013
- Descendant · cites it directly · 0 of its ownK130704 Microdose SIPhilips Digital Mammography Sweden AB · 2013
Most influential descendants
Showing 1 of 1 · See all- K130704Microdose SIPhilips Digital Mammography Sweden AB · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P990066 | GE Healthcare Senographe Full Field Digital Mammography System | GE Healthcare | 2000 | 4 |
| −2 | K110025 | Sectra Microdose Mammography | Sectra Imtec AB | 2011 | — |
| −1 | K120255 | Philips Microdose | Philips Digital Mammography Sweden AB | 2012 | — |
| 0 (this device) | K123995 | Microdose SI | Philips Digital Mammography Sweden AB | 2013 | — |
| +1 | 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 | 1 | 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 |
|---|---|---|---|
| * | K110025 | Sectra Microdose MammographySummary page 2…CE Predicate device Device Classification Full Field Digital, Systerti, X-ray, Mamnmographic Name 510(k) Number 1(110025, K120255 Device Name Philips MicroDose Model [30 Applicant Philips… | 2011 |
| * | K120255 | Philips MicrodoseSummary page 2…Predicate device Device Classification Full Field Digital, Systerti, X-ray, Mamnmographic Name 510(k) Number 1(110025, K120255 Device Name Philips MicroDose Model [30 Applicant Philips Digital M… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130704 | Microdose SI | 2013 | 0 |
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 13 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K130704 (Philips Digital Mammography Sweden AB, 2013) has gone furthest, with 0 descendants 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. 2013, 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 MicroDose SI (model L50) is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MicroDose SI (model L50) 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/K123995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123995: Microdose SI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123995
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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