510(k) Report

FDA applicant

Nomos Corp.

Sewickley, PA21 decisions1993–20070 recalls

FDA records 21 decisions for Nomos Corp. (Sewickley, PA) from 1993 to 2007: 21 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and HAW (Neurological Stereotaxic Instrument). Its devices cite 35 predicates, 11 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 Nomos Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nomos Corp.’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, Medical12decisions
  • HAWNeurological Stereotaxic Instrument3decisions
  • JAICouch, Radiation Therapy, Powered3decisions
  • MUJSystem, Planning, Radiation Therapy Treatment2decisions
  • IXIBlock, Beam-Shaping, Radiation Therapy1decision

Whose devices does it build on?

Its devices cite 35 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 11 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.

  • K940663Peacock PlanNomos Corp. · 19967cite it
  • K955397Mayfield-Acciss WorkstationNomos Corp. · 19965cite it
  • K981424Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp. · 19984cite it
  • K963258Peacock SystemNomos Corp. · 19963cite it
  • K941927The Nomos CraneNomos Corp. · 19952cite it
  • K993675Peregrine Radiation Therapy Dose Calculation SystemNomos Corp. · 20001cites it

What has FDA decided for it lately?

  • K070611Bat Ultrasound Localization and Positioning System, Version 6Nomos Corp. · 2007
  • K060895Nomosstat, Version 1.0Nomos Corp. · 2006
  • K042875NavigatorNomos Corp. · 2005
  • K032209Nomos Corvus 5.0MNomos Corp. · 2003
  • K013036Nomos Motorized Crane IINomos Corp. · 2001
  • K993675Peregrine Radiation Therapy Dose Calculation SystemNomos Corp. · 2000
  • K993359Raptor Treatment Planning SystemNomos Corp. · 1999
  • K991966The Nomos Chane IINomos Corp. · 1999

All 21 as Nomos Corp. →