510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854499Substantially Equivalent

Gendex Prince 30 Medical X-Ray Generator

Gendex Corp., Franklin Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854499 is the FDA 510(k) clearance record for GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR, a class I device, cleared for Gendex Corp. on under FDA product code IZO (Generator, High-Voltage, X-Ray, Diagnostic). FDA records list 16 510(k) clearances for Gendex Corp., from to . As of , FDA records show no recalls naming K854499.

Clearance record

Decision date
Received
(161 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
Gendex Corp. 11341 W. Melrose St., Franklin Park IL
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IZO, 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