Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

EAP — Predicate Candidate Screening

42 FDA 510(k) clearances under this product code; the 50 most recent screened below.

70 daysmedian FDA review time

220 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days
K113360	MEDICAL IMAGE PROCESSING UNIT	Humanray Co,Ltd	2012-02-07	85
K102573	PROVU (TM) DENTAL X-RAY SYSTEM	Advanced Image Science, Inc.	2011-06-30	294
K093453	MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM	Schick Technologies, Inc.	2009-11-30	25
K080738	DENTRON SENSOR	Dentron Systems, LLC	2008-05-13	57
K052422	THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED A	Flow X-Ray Corp.	2005-09-27	25
K041385	MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM	Schick Technologies, Inc.	2004-06-07	13
K960819	HELIODENT DS	Pelton & Crane Co.	1996-03-29	29
K960028	ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM	Dentsply Intl.	1996-03-01	59
K953936	ATLANTIS	Trophy Radiologie	1995-12-28	129
K954565	EXPLOR-X (AZTEH) HF	Chicago X-Ray Systems, Inc.	1995-10-27	25
K951734	LUMIX 70B	Emix U.S.A., Inc.	1995-07-20	97
K950533	TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY	Trophy Radiologie	1995-06-30	147
K950532	TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY	Trophy Radiologie	1995-04-19	71
K950667	AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER	Chicago X-Ray Systems, Inc.	1995-04-06	52
K950030	HELIODENT MD	Pelton & Crane Co.	1995-02-03	30
K934645	RADWORKS	Radworks Corp.	1994-08-17	330
K936068	ORTHOPHOS 3/ ORTHOPHOS 3C	Pelton & Crane Co.	1994-07-29	220
K933455	COMPUTED ORAL RADIOLOGY SYSTEM	Schick Technologies, Inc.	1994-01-31	201
K931486	INTREX VSK INTERORAL DENTAL X-RAY UNIT	Keystone X-Ray, Inc.	1993-11-23	244
K931717	YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY	Kaycor Intl., Ltd.	1993-09-20	167
K930925	INTREX INTERORAL DENTAL X-RAY UNIT	Keystone X-Ray, Inc.	1993-07-13	140
K930761	IMAGE-X 70 INTRAORAL X-RAY SYSTEM	Afp Imaging Corp.	1993-05-25	102
K923307	HEALTHPAK X-RAY SOX BARRIERS	Healthpak, Inc.	1993-01-21	258
K900681	PANORAMIC MODEL X-CALIBER X-RAY	Belmont Equipment Corp.	1990-05-23	100
K896963	TRIMODE SP DENTAL INTRA ORAL X-RAY	Tempo Technology, Inc.	1990-01-22	38
K896024	MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE	Mdt Diagnostic Co.	1990-01-22	98
K883354	VARIABLE KV INTREX VSK 60 - 90 KVP	Keystone X-Ray, Inc.	1988-12-21	134
K882379	MINIM-X 2001-CIAS & MINIM-X 2002-CIAS	Dentomar, Inc.	1988-09-09	92
K861328	NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY	Belmont Equipment Corp.	1986-04-24	15
K852019	BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD	Belmont Equipment Corp.	1985-06-05	28
K834279	ACURAY 071A DENTAL INTRAORAL X-RAY	Belmont Equipment Corp.	1983-12-29	37
K833241	INTREX	Pennwalt Corp.	1983-10-28	67
K832065	ACURACY 071, DENTAL, INTRAORAL-X-RAY	Belmont Equipment Corp.	1983-09-12	77
K800063	XR-710	Pennwalt Corp.	1980-03-03	52
K792535	PORTARAY	Siemens Corp.	1980-01-28	52
K792437	RAFLEX 70	Mdt Corp., Inc.	1980-01-09	42
K792307	DENTIX DENTAL X-RAY UNIT	Precise Optics	1980-01-09	54
K791014	DENTAL XERORADIOGRAPHY	Xerox Medical Systems	1979-09-04	95
K781630	GE-700 INTRA ORAL X-RAY SYSTEM	General Electric Co.	1978-12-04	70
K772184	X-RAY SYSTEM FOR DENTAL APPLICATION	General Electric Co.	1977-12-22	27
K770345	X-RAY TUBE - PANOBEAM	Thoro-Ray, Inc.	1977-03-08	14
K760323	X-RAY UNIT, DENTAL DIAGNOSTIC	The S. S. White Co.	1976-08-03	8

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