Name: Predicase
Price: 199 USD

K-number	K160853
Device name	Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System
Applicant	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
Product code	IYN
Device class	Class II
Decision date	Jun 27, 2016
Decision	Substantially Equivalent
Regulation	892.1550

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 →

Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System

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