510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921951Substantially Equivalent

Mpg 65-80-100 X-Ray Generator and Control

General Electric Co., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921951 is the FDA 510(k) clearance record for MPG 65-80-100 X-RAY GENERATOR AND CONTROL, a class I device, cleared for General Electric Co. on under FDA product code IZO (Generator, High-Voltage, X-Ray, Diagnostic). FDA records list 256 510(k) clearances for General Electric Co., from to . As of , FDA records show no recalls naming K921951.

Clearance record

Decision date
Received
(85 days to decision)
Product code
IZO Generator, High-Voltage, X-Ray, Diagnostic
Regulation
21 CFR 892.1700
Device class
Class I
Review panel
Radiology
Applicant
General Electric Co. P.O. Box 414, Milwaukee WI
510(k) summary
Summary
Third party review
No

Clearances, product code IZO

Trailing 12 months

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

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