510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K123249Substantially Equivalent

Diagnostic Ultrasound System

Edan Instruments, Inc., Shenzhen, Guangdong, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123249 is the FDA 510(k) clearance record for DIAGNOSTIC ULTRASOUND SYSTEM, a class II device, cleared for Edan Instruments, Inc. on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 94 510(k) clearances for Edan Instruments, Inc., from to . As of , FDA records show no recalls naming K123249.

Clearance record

Decision date
Received
(114 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Edan Instruments, Inc. Equipments Park, Nanhai Rd., Shenzhen, Guangdong, CN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IYN

Trailing 12 months
50 clearances under product code IYN in the twelve months to November 2026, May 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code IYN, trailing twelve months
MonthClearances
December 20256
January 20264
February 20261
March 20266
April 20263
May 202611
June 20263
July 20266
August 20263
September 20263
October 20264
November 20260