510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111209Substantially Equivalent

Integrated Innova - S5i System Option

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

K111209 is the FDA 510(k) clearance record for INTEGRATED INNOVA - S5I SYSTEM OPTION, 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 2 recalls naming K111209.

Clearance record

Decision date
Received
(88 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 283, Rue De La Miniere, Buc, FR
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 October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IZI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20262
June 20260
July 20260
August 20260
September 20260
October 20260