510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K061163Substantially Equivalent

Innova 2121Iq, Innova 3131Iq, Innova 4100, Innova 4100Iq, Innova 3100, Innova 3100Iq, Innova 2100Iq with Innova Ivus Opt

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

K061163 is the FDA 510(k) clearance record for INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT, a class II device, cleared for Ge Medical Systems, LLC on under FDA product code OWB (Interventional Fluoroscopic X-Ray System). FDA's definition for product code OWB reads: "Interventional fluoroscopy". FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show 38 recalls naming K061163.

Clearance record

Decision date
Received
(42 days to decision)
Product code
OWB Interventional Fluoroscopic X-Ray System
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Applicant
Ge Medical Systems, LLC 3000 N. Grandview Blvd., Waukesha WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWB

Trailing 12 months
19 clearances under product code OWB in the twelve months to October 2026, April 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code OWB, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20262
March 20262
April 20264
May 20261
June 20260
July 20262
August 20263
September 20260
October 20260