Name: Predicase
Price: 199 USD

K-number	K964647
Device name	NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
Applicant	North American Scientific, Inc.
Product code	KXK
Device class	Class II
Decision date	Feb 10, 1997
Decision	Substantially Equivalent
Regulation	892.5730

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE

Everything you need for a 510(k) submission. Nothing you don't.