510(k) Report

FDA applicant

Philips Digital Mammography Sweden AB

Solna, SE3 decisions2012–20130 recalls

FDA records 3 decisions for Philips Digital Mammography Sweden AB (Solna, SE) from 2012 to 2013: 3 510(k) clearances. All are in product code MUE (Full Field Digital, System, X-Ray, Mammographic). Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Philips Digital Mammography Sweden AB’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2012: 12013: 2
2012high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Philips Digital Mammography Sweden AB by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Philips Digital Mammography Sweden AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MUEFull Field Digital, System, X-Ray, Mammographic3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123995Microdose SIPhilips Digital Mammography Sweden AB · 20131cites it
  • K120255Philips MicrodosePhilips Digital Mammography Sweden AB · 20121cites it

What has FDA decided for it lately?

  • K130704Microdose SIPhilips Digital Mammography Sweden AB · 2013
  • K123995Microdose SIPhilips Digital Mammography Sweden AB · 2013
  • K120255Philips MicrodosePhilips Digital Mammography Sweden AB · 2012

All 3 as Philips Digital Mammography Sweden AB →