Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Gendex Corp. — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

98 daysmedian FDA review time

200 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K952598	GX-PAN PANORAMIC DENTAL X-RAY SYSTEM	Gendex Corp.	1995-06-29	23
K945682	PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL	Gendex Corp.	1995-02-09	80
K935046	GX-770 X-RAY CONTROL, MODEL 46-404600G4	Gendex Corp.	1994-02-18	121
K925094	VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS	Gendex Corp.	1993-09-29	357
K931001	ORALIX DC	Gendex Corp.	1993-09-14	200
K932675	GXP DENTAL X-RAY PROCESSOR	Gendex Corp.	1993-07-26	54
K922165	ATC725, ATC525, AND AP300	Gendex Corp.	1992-07-27	80
K920189	GX-C CEPHALOMETER	Gendex Corp.	1992-04-28	104
K894188	GX-ELEVATOR	Gendex Corp.	1989-10-03	109
K890083	GX-2000 STATIONARY X-RAY GENERATOR	Gendex Corp.	1989-03-31	80
K873982	GX-MOBILE X-RAY UNIT	Gendex Corp.	1987-10-30	30
K854499	GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR	Gendex Corp.	1986-04-22	161
K854459	TBX MEDICAL X-RAY TABLE	Gendex Corp.	1986-02-12	98
K842463	GX CEPH	Gendex Corp.	1984-08-02	41

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda