Name: Predicase
Price: 199 USD

K-number	K181415
Device name	XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
Applicant	Canon Medical Systems Corporation
Product code	OWB
Device class	Class II
Decision date	Sep 10, 2018
Decision	Substantially Equivalent
Regulation	892.1650

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 →

XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0

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