510(k) Report

FDA applicant

Siemens Medi Cal Solutions, Inc.

Malvern, PA32 decisions2004–202055 recalls

FDA records 32 decisions for Siemens Medi Cal Solutions, Inc. (Malvern, PA) from 2004 to 2020: 32 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 118 days from receipt to decision, against 64 for FDA’s reviews in the same codes and years. Its devices cite 69 predicates, 2 of them its own earlier devices. 55 recalls are linked to its devices, 4 Class I.

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 Medi Cal Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2008: 12009: 22011: 12012: 12013: 22014: 42015: 22016: 52017: 22018: 42019: 22020: 1
2007high 5 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

7in 2025

2015: 42016: 32018: 22019: 52020: 122021: 42022: 122024: 32025: 7, 4 Class I
2007high 12 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Siemens Medi Cal Solutions, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic7decisions
  • LNHSystem, Nuclear Magnetic Resonance Imaging5decisions
  • JAKSystem, X-Ray, Tomography, Computed4decisions
  • LLZSystem, Image Processing, Radiological3decisions
  • KPRSystem, X-Ray, Stationary3decisions
  • OWBInterventional Fluoroscopic X-Ray System3decisions

Also: DQK (2), OEB (1), MUE (1), IZL (1), IYO (1), MOS (1).

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 118 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 64 days; 5 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 69 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 79 times; 2 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.

  • K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 201216cite it
  • K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 20168cite it
  • K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 20116cite it
  • K052423Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 20066cite it
  • K132094Cios AlphaSiemens Medi Cal Solutions, Inc. · 20145cite it
  • K090334Acuson S2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 20094cite it

What has FDA decided for it lately?

  • K193216syngo.CT Lung CADSiemens Medi Cal Solutions, Inc. · 2020
  • K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc. · 2019
  • K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc. · 2019
  • K181279Ysio MaxSiemens Medi Cal Solutions, Inc. · 2018
  • K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc. · 201823 recalls
  • K173408Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 20182 recalls
  • K172832Insight BDSiemens Medi Cal Solutions, Inc. · 2018
  • K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2017

All 32 as Siemens Medi Cal Solutions, Inc. →

What has been recalled?

55 recalls linked to its devices; the latest:

  • K173639LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471Dec 5, 2025Class II
  • K132119MAGNETOM Prisma. Model Number: 10849582.Aug 28, 2025Class I
  • K121434MAGNETOM Verio Dot Upgrade. Model Number: 10684334.Aug 28, 2025Class I
  • K121434MAGNETOM Verio Dot. Model Number: 10684333.Aug 28, 2025Class I
  • K130885MAGNETOM Skyra fit. Model Number: 10849580.Aug 28, 2025Class I
  • K101491UROSKOP Omnia Max. Model Number: 10762473Jun 4, 2025Class II