Name: Predicase
Price: 199 USD

K-number	K080062
Device name	OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120
Applicant	Hitachi Medical Systems America, Inc.
Product code	MOS
Device class	Class II
Decision date	Feb 11, 2008
Decision	Substantially Equivalent
Regulation	892.1000

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 →

OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120

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