510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K910902Substantially Equivalent

Vmx Mobile X-Ray System

GE Healthcare, Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910902 is the FDA 510(k) clearance record for VMX MOBILE X-RAY SYSTEM, a class II device, cleared for GE Medical Systems on under FDA product code IZL (System, X-Ray, Mobile). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show one recall naming K910902.

Clearance record

Decision date
Received
(188 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
GE Medical Systems P.O. Box 414, Milwaukee WI
Third party review
No

Clearances, product code IZL

Trailing 12 months
7 clearances under product code IZL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20261
July 20260
August 20261
September 20260
October 20261