510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052412Substantially Equivalent

Innova 2100-Iq, Innova 3100, Innova 3100-Iq, Innova 4100, and Innova 4100-Iq

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

K052412 is the FDA 510(k) clearance record for INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ, a class II device, cleared for GE Healthcare 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 50 recalls naming K052412.

Clearance record

Decision date
Received
(14 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 Healthcare 3000 N. Grandview Blvd., Waukesha WI
510(k) summary
Summary PDF
Third party review
Yes

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