510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K944967Substantially Equivalent

Tomo-Link

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

K944967 is the FDA 510(k) clearance record for TOMO-LINK, a class II device, cleared for GE Medical Systems on under FDA product code IZF (System, X-Ray, Tomographic). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K944967.

Clearance record

Decision date
Received
(59 days to decision)
Product code
IZF System, X-Ray, Tomographic
Regulation
21 CFR 892.1740
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 IZF

Trailing 12 months
1 clearance under product code IZF in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260