FDA applicant
North American Scientific, Inc.
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
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.
Planning a device like North American Scientific, 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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