510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960146Substantially Equivalent

G.e. Sterile Disposable Radiographic Contrast Tray

GE Healthcare, Palm Harbor FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960146 is the FDA 510(k) clearance record for G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY, a class II device, cleared for GE Medical Systems on under FDA product code IZG (System, X-Ray, Photofluorographic). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K960146.

Clearance record

Decision date
Received
(42 days to decision)
Product code
IZG System, X-Ray, Photofluorographic
Regulation
21 CFR 892.1730
Device class
Class II
Review panel
Radiology
Applicant
GE Medical Systems 1247 Flordia Ave., Palm Harbor FL
510(k) summary
Statement
Third party review
No

Clearances, product code IZG

Trailing 12 months

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

FDA records show no clearances under product code IZG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IZG, 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