510(k) Report

FDA applicant

Siemens Medical Solution

Mavern, PA5 decisions2004–20126 recalls

FDA records 5 decisions for Siemens Medical Solution (Mavern, PA) from 2004 to 2012: 4 510(k) clearances and 1 original PMA approval. Most are in product codes MUE (Full Field Digital, System, X-Ray, Mammographic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 11 predicates, 0 of them its own earlier devices. 6 recalls are 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 Siemens Medical Solution’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2012: 2
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2009: 12014: 12016: 22018: 1
2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Siemens Medical Solution by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Siemens Medical Solution’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, Mammographic1decision
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision
  • JAKSystem, X-Ray, Tomography, Computed1decision
  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision
  • KPRSystem, X-Ray, Stationary1decision

Whose devices does it build on?

Its devices cite 11 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • P030010Siemens Mammomat Novationdr Full Field Digital Mammography SystemSiemens Medical Solution · 20046cite it
  • K121513Multix FusionSiemens Medical Solution · 20126cite it
  • K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 20123cite it
  • K050199Magnetom Symphony a Tim SystemSiemens Medical Solution · 20053cite it
  • K061449Syngo Expert-1Siemens Medical Solution · 20062cite it

What has FDA decided for it lately?

  • K121513Multix FusionSiemens Medical Solution · 20124 recalls
  • K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
  • K061449Syngo Expert-1Siemens Medical Solution · 2006
  • K050199Magnetom Symphony a Tim SystemSiemens Medical Solution · 2005
  • P030010Siemens Mammomat Novationdr Full Field Digital Mammography SystemSiemens Medical Solution · 20042 recalls

All 5 as Siemens Medical Solution →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K121513Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model…Aug 3, 2018Class II
  • K121513Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a…Aug 1, 2016Class II
  • K121513Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system…Aug 1, 2016Class II
  • K121513MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals…Feb 13, 2014Class II
  • P030010Siemens Mammomat Novation DR, full field digital mammography system. Model Number…Jan 23, 2009
  • P030010Mammomat Novation Digital Mammography System. Model number 6646900May 25, 2005