Name: Predicase
Price: 199 USD

K-number	K202353
Device name	SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System
Applicant	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
Product code	IZL
Device class	Class II
Decision date	Dec 23, 2020
Decision	Substantially Equivalent
Regulation	892.1720

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 →

SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System

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