510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945682Substantially Equivalent

Processor, Radiographic-Film, Automatic, Dental

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

K945682 is the FDA 510(k) clearance record for PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL, a class II device, cleared for Gendex Corp. on under FDA product code EGY (Processor, Radiographic-Film, Automatic, Dental). FDA records list 16 510(k) clearances for Gendex Corp., from to . As of , FDA records show no recalls naming K945682.

Clearance record

Decision date
Received
(80 days to decision)
Product code
EGY Processor, Radiographic-Film, Automatic, Dental
Regulation
21 CFR 892.1900
Device class
Class II
Review panel
Radiology
Applicant
Gendex Corp. 901 W. Oakton St., Des Plaines IL
510(k) summary
Statement
Third party review
No

Clearances, product code EGY

Trailing 12 months

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

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