Name: Predicase
Price: 199 USD

K-number	K163140
Device name	SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
Applicant	Gemss Medical Systems Co., Ltd.
Product code	OWB
Device class	Class II
Decision date	May 26, 2017
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 →

SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System

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