510(k) Report

FDA applicant

Siemens Medical Laboratories, Inc.

Walnut Creek, CA13 decisions1979–199159 recalls

FDA records 13 decisions for Siemens Medical Laboratories, Inc. (Walnut Creek, CA) from 1979 to 1991: 13 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and DXK (Echocardiograph). 59 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 Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Siemens Medical Laboratories, Inc. since 2007.

Recalls per year

2in 2020

2007: 262008: 32010: 42011: 182014: 12017: 52020: 2
2007high 26 (2007) · low 0 (2009)2026

Class I Class II/III not classified

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

Planning a device like Siemens Medical Laboratories, Inc.’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?

  • IYEAccelerator, Linear, Medical9decisions
  • DXKEchocardiograph1decision
  • JADSystem, Therapeutic, X-Ray1decision
  • LHNSystem, Radiation Therapy, Charged-Particle, Medical1decision
  • JAICouch, Radiation Therapy, Powered1decision

Who builds on its devices?

Later devices cite its devices 10 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.

  • K882729Mevatron, M 2 ClassSiemens Medical Laboratories, Inc. · 19883cite it
  • K910971Z XT Radiation Therapy Treatment TableSiemens Medical Laboratories, Inc. · 19913cite it
  • K862339Mevatron KD-2Siemens Medical Laboratories, Inc. · 19862cite it
  • K852907Siemens Mevatron MESiemens Medical Laboratories, Inc. · 19851cites it
  • K903139Beamview & Beamview Plus (Aka Project 743)Siemens Medical Laboratories, Inc. · 19901cites it

What has FDA decided for it lately?

  • K910971Z XT Radiation Therapy Treatment TableSiemens Medical Laboratories, Inc. · 1991
  • K903139Beamview & Beamview Plus (Aka Project 743)Siemens Medical Laboratories, Inc. · 19901 recall
  • K894230Patient Data Management System (Project 735)Siemens Medical Laboratories, Inc. · 1989
  • K882729Mevatron, M 2 ClassSiemens Medical Laboratories, Inc. · 198838 recalls
  • K875272Sonoline CFSiemens Medical Laboratories, Inc. · 1988
  • K862339Mevatron KD-2Siemens Medical Laboratories, Inc. · 198616 recalls
  • K854609Mevamatic 3Siemens Medical Laboratories, Inc. · 1986
  • K852907Siemens Mevatron MESiemens Medical Laboratories, Inc. · 1985

All 13 as Siemens Medical Laboratories, Inc. →

What has been recalled?

59 recalls linked to its devices; the latest:

  • K882729MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2…Feb 18, 2020Class II
  • K882729ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR…Feb 18, 2020Class II
  • K812032MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS…Jan 25, 2017Class II
  • K791967MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS…Jan 25, 2017Class II
  • K882729MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended…Jan 25, 2017Class II
  • K790688MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SIEMENS…Jan 25, 2017Class II