510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K113034Substantially Equivalent

Ge Innova Solid State XRAY Imager Flurosopic X Ray System

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

K113034 is the FDA 510(k) clearance record for GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM, a class II device, cleared for GE Healthcare on under FDA product code IZI (System, X-Ray, Angiographic). FDA records list 888 510(k) clearances for GE Healthcare, from to . As of , FDA records show no recalls naming K113034.

Clearance record

Decision date
Received
(63 days to decision)
Product code
IZI System, X-Ray, Angiographic
Regulation
21 CFR 892.1600
Device class
Class II
Review panel
Radiology
Applicant
GE Healthcare 9900 Innovation Dr., Wauwatosa WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZI

Trailing 12 months
2 clearances under product code IZI in the twelve months to November 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IZI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20262
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260