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 Dec 13, 2013 as substantially equivalent to K123995 (Philips Digital Mammography Sweden AB, 2013) and 2 other predicates after a 273-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Dec 13, 2013
- Review
- 273 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K904519 (1991). 26 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 5 generations between
- 3 generations backK082483 QuantraHologic, Inc. · 2008
- 2 generations backK102556 Volpara, Version 1.3Matakina Technology Limited · 2010
- 1 generation backK120472 QuantraHologic, Inc. · 2012
- This deviceK130704 Microdose SIPhilips Digital Mammography Sweden AB · 2013
Show all 9 generations
- Root · 9 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 8 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 7 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 6 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 5 generations backK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · Recalled
- 4 generations backK073272 Workstationone Breast Imaging WorkstationThree Palm Software, LLC · 2007
- 3 generations backK082483 QuantraHologic, Inc. · 2008
- 2 generations backK102556 Volpara, Version 1.3Matakina Technology Limited · 2010
- 1 generation backK120472 QuantraHologic, Inc. · 2012
- This deviceK130704 Microdose SIPhilips Digital Mammography Sweden AB · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −8 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −7 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −6 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −5 | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | 1 |
| −4 | K073272 | Workstationone Breast Imaging Workstation | Three Palm Software, LLC | 2007 | — |
| −3 | K082483 | Quantra | Hologic, Inc. | 2008 | — |
| −2 | K102556 | Volpara, Version 1.3 | Matakina Technology Limited | 2010 | — |
| −1 | K120472 | Quantra | Hologic, Inc. | 2012 | — |
| 0 (this device) | K130704 | Microdose SI | Philips Digital Mammography Sweden AB | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K123995 | Microdose SISummary page 1…21 CFR 892.1715, 21 CFR 892.2050 (secondary) C. DEVICE DESCRIPTION This application is to add functionality to the previously cleared MicroDose SI, Model 150, (K123995) that allows for breast density measurements. The L50 submission described that the detector electronics have been modified to… | 2013 |
| * | K102556 | Volpara, Version 1.3Summary page 2…oDose SI(model -MicroDose Si(model Voipara Quantra L50) - L50) ~ K102556 K(12G472 Subject device K123995 Predicate… | 2010 |
| * | K120472 | QuantraSummary page 3…olose SI(model Volpara Quantra 150) -50) 6K02556- K120472 * Subject device K123995.. : Predicate -Predicate… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 26 ancestors have a recall of any class.
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/K130704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130704: 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/K130704
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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