510(k) Report

FDA applicant

Gamma Medica

Northridge, CA1 decision2000–20000 recalls

FDA records 1 decision for Gamma Medica (Northridge, CA) in 2000: 1 510(k) clearance. All are in product code IYX (Camera, Scintillation (Gamma)). Its devices cite 3 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 Gamma Medica’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gamma Medica since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gamma Medica 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?

  • IYXCamera, Scintillation (Gamma)1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K993813Lumagem Scintillation CameraGamma Medica · 20003cite it

What has FDA decided for it lately?

  • K993813Lumagem Scintillation CameraGamma Medica · 2000

The one decision as Gamma Medica →

Other applicant names beginning “Gamma”

FDA records each applicant name separately; these may or may not be the same firm.

Gamma Enterprises, Inc. 23Gamma Biologicals, Inc. 21Gamma Medica-Ideas Incorporated 2Gamma Medical Products, Inc. 2