510(k) Report

FDA applicant

American Radiosurgery, Inc.

San Diego, CA3 decisions2006–20100 recalls

FDA records 3 decisions for American Radiosurgery, Inc. (San Diego, CA) from 2006 to 2010: 3 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and IWB (System, Radiation Therapy, Radionuclide). Its devices cite 2 predicates, 1 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 American Radiosurgery, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like American Radiosurgery, 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?

  • MUJSystem, Planning, Radiation Therapy Treatment2decisions
  • IWBSystem, Radiation Therapy, Radionuclide1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K093588Explorer 4D Treatment Planning SystemAmerican Radiosurgery, Inc. · 20101cites it
  • K101220Explorer 4D Treatment Planning SystemAmerican Radiosurgery, Inc. · 20101cites it
  • K060314Rotating Gamma System. Gamma Art-6000American Radiosurgery, Inc. · 20061cites it

What has FDA decided for it lately?

  • K101220Explorer 4D Treatment Planning SystemAmerican Radiosurgery, Inc. · 2010
  • K093588Explorer 4D Treatment Planning SystemAmerican Radiosurgery, Inc. · 2010
  • K060314Rotating Gamma System. Gamma Art-6000American Radiosurgery, Inc. · 2006

All 3 as American Radiosurgery, Inc. →