510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111304Substantially Equivalent

Optima Xr120

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

K111304 is the FDA 510(k) clearance record for OPTIMA XR120, a class II device, cleared for Ge Medical Systems, LLC on under FDA product code IXL (Device, Spot-Film). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K111304.

Clearance record

Decision date
Received
(71 days to decision)
Product code
IXL Device, Spot-Film
Regulation
21 CFR 892.1670
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 IXL

Trailing 12 months

FDA records hold no clearances under product code IXL in the trailing twelve months.

FDA records show no clearances under product code IXL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IXL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260