510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K090229Substantially Equivalent

Diagnostic Doppler Ultrasound System 2-5Mhz Curved Linear Array, 5-10Mhz Linear Array, 2-4Mhz Phase Array, 4-8Mhz Transv

Chang Gung Medical Supplies & Equipment Corp., Dublin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090229 is the FDA 510(k) clearance record for DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV, a class II device, cleared for Chang Gung Medical Supplies & Equipment Corp. on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list one 510(k) clearance for Chang Gung Medical Supplies & Equipment Corp. As of , FDA records show no recalls naming K090229.

Clearance record

Decision date
Received
(42 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Chang Gung Medical Supplies & Equipment Corp. 7263 Cronin Cir., Dublin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYN

Trailing 12 months
53 clearances under product code IYN in the twelve months to October 2026, May 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code IYN, trailing twelve months
MonthClearances
November 20256
December 20256
January 20264
February 20261
March 20266
April 20263
May 202611
June 20263
July 20266
August 20263
September 20263
October 20261