510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K043076Substantially Equivalent

Ge Oec Fluorostar

GE Healthcare, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K043076 is the FDA 510(k) clearance record for GE OEC FLUOROSTAR, a class II device, cleared for Ge Oec Medical Systems, Inc. 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 one recall naming K043076.

Clearance record

Decision date
Received
(44 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 Oec Medical Systems, Inc. 384 Wright Brothers Dr., Salt Lake City UT
510(k) summary
Statement
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