Name: Predicase
Price: 199 USD

K-number	K101008
Device name	DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY
Applicant	Shantou Institute of Ultrasonic Instruments (Siui
Product code	ITX
Device class	Class II
Decision date	Jun 8, 2010
Decision	Substantially Equivalent
Regulation	892.1570

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 →

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY

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