510(k) Report

FDA applicant

Advanced Radiation Therapy Systems, Inc.

King Oof Prussia, PA1 decision1998–19980 recalls

FDA records 1 decision for Advanced Radiation Therapy Systems, Inc. (King Oof Prussia, PA) in 1998: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 2 predicates, 0 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 Advanced Radiation Therapy Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Radiation Therapy Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Advanced Radiation Therapy Systems, 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, Medical1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K972816Advanced Treatment Planning SystemAdvanced Radiation Therapy Systems, Inc. · 1998

The one decision as Advanced Radiation Therapy Systems, Inc. →