510(k) Report

FDA applicant

American Biophysics, Inc.

Mccordsville, IN1 decision1998–19980 recalls

FDA records 1 decision for American Biophysics, Inc. (Mccordsville, IN) in 1998: 1 510(k) clearance. All are in product code JAI (Couch, Radiation Therapy, Powered). Its devices cite 1 predicate, 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 American Biophysics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Biophysics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JAICouch, Radiation Therapy, Powered1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K982446Dynamic Shielding Radiation TableAmerican Biophysics, Inc. · 1998

The one decision as American Biophysics, Inc. →