Name: Predicase
Price: 199 USD

K-number	K201004
Device name	Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W
Applicant	Iray Technology Taicang , Ltd.
Product code	MQB
Device class	Class II
Decision date	May 1, 2020
Decision	Substantially Equivalent
Regulation	892.1680

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 →

Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W

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