510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K030934Substantially Equivalent

Ge Logiq 9 Model 2375600

GE Healthcare, Milwaukee WI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030934 is the FDA 510(k) clearance record for GE LOGIQ 9 MODEL 2375600, a class II device, cleared for Ge Medical Systems, Inc. on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K030934.

Clearance record

Decision date
Received
(23 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Ge Medical Systems, Inc. P.O. Box 414, Milwaukee WI
510(k) summary
Summary PDF
Third party review
No

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