Name: Predicase
Price: 199 USD

K-number	K122897
Device name	SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645
Applicant	Invivo Corporation
Product code	MOS
Device class	Class II
Decision date	Dec 21, 2012
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 →

SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645

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