510(k) Report

FDA applicant

Rsa, Inc.

Brookline, MA1 decision1991–19910 recalls

FDA records 1 decision for Rsa, Inc. (Brookline, MA) in 1991: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). 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 Rsa, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rsa, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rsa, 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?

  • IYEAccelerator, Linear, Medical1decision

Who builds on its devices?

Later devices cite its devices 5 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.

  • K912630Xknife Radiosurgery SystemRsa, Inc. · 19915cite it

What has FDA decided for it lately?

  • K912630Xknife Radiosurgery SystemRsa, Inc. · 1991

The one decision as Rsa, Inc. →