510(k) Report

FDA applicant

North American Scientific, Inc.

Chatsworth, CA4 decisions1997–20060 recalls

FDA records 4 decisions for North American Scientific, Inc. (Chatsworth, CA) from 1997 to 2006: 4 510(k) clearances. Most are in product codes KXK (Source, Brachytherapy, Radionuclide) and JAQ (System, Applicator, Radionuclide…). 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 North American Scientific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for North American Scientific, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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