510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K965010Substantially Equivalent

Target 2 Version 1.1

GE Healthcare, Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965010 is the FDA 510(k) clearance record for TARGET 2 VERSION 1.1, a class II device, cleared for GE Medical Systems on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K965010.

Clearance record

Decision date
Received
(219 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
GE Medical Systems P.O. Box 414, Milwaukee WI
510(k) summary
Summary
Third party review
No

Clearances, product code IYE

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