Name: Predicase
Price: 199 USD

K-number	K113341
Device name	GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
Applicant	Hitachi Medical Systems America, Inc.
Product code	JAK
Device class	Class II
Decision date	May 3, 2012
Decision	Substantially Equivalent
Regulation	892.1750

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 →

GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM

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