FDA 510(k) Applications for Medical Device Product Code "EAP"
(Unit, X-Ray, Intraoral)

FDA 510(k) Number Applicant Device Name Decision Date
K102573 ADVANCED IMAGE SCIENCE, INC. PROVU (TM) DENTAL X-RAY SYSTEM 06/30/2011
K930761 AFP IMAGING CORP. IMAGE-X 70 INTRAORAL X-RAY SYSTEM 05/25/1993
K832065 BELMONT EQUIPMENT CORP. ACURACY 071, DENTAL, INTRAORAL-X-RAY 09/12/1983
K834279 BELMONT EQUIPMENT CORP. ACURAY 071A DENTAL INTRAORAL X-RAY 12/29/1983
K852019 BELMONT EQUIPMENT CORP. BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD 06/05/1985
K861328 BELMONT EQUIPMENT CORP. NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY 04/24/1986
K900681 BELMONT EQUIPMENT CORP. PANORAMIC MODEL X-CALIBER X-RAY 05/23/1990
K950667 CHICAGO X-RAY SYSTEMS, INC. AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER 04/06/1995
K954565 CHICAGO X-RAY SYSTEMS, INC. EXPLOR-X (AZTEH) HF 10/27/1995
K882379 DENTOMAR, INC. MINIM-X 2001-CIAS & MINIM-X 2002-CIAS 09/09/1988
K080738 DENTRON SYSTEMS LLC DENTRON SENSOR 05/13/2008
K960028 DENTSPLY INTL. ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM 03/01/1996
K951734 EMIX U.S.A., INC. LUMIX 70B 07/20/1995
K052422 FLOW X-RAY CORP. THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) 09/27/2005
K781630 GENERAL ELECTRIC CO. GE-700 INTRA ORAL X-RAY SYSTEM 12/04/1978
K772184 GENERAL ELECTRIC CO. X-RAY SYSTEM FOR DENTAL APPLICATION 12/22/1977
K923307 HEALTHPAK, INC. HEALTHPAK X-RAY SOX BARRIERS 01/21/1993
K113360 HUMANRAY CO,LTD MEDICAL IMAGE PROCESSING UNIT 02/07/2012
K931717 KAYCOR INTL., LTD. YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY 09/20/1993
K930925 KEYSTONE X-RAY, INC. INTREX INTERORAL DENTAL X-RAY UNIT 07/13/1993
K931486 KEYSTONE X-RAY, INC. INTREX VSK INTERORAL DENTAL X-RAY UNIT 11/23/1993
K883354 KEYSTONE X-RAY, INC. VARIABLE KV INTREX VSK 60 - 90 KVP 12/21/1988
K792437 MDT CORP., INC. RAFLEX 70 01/09/1980
K896024 MDT DIAGNOSTIC CO. MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE 01/22/1990
K960819 PELTON & CRANE CO. HELIODENT DS 03/29/1996
K950030 PELTON & CRANE CO. HELIODENT MD 02/03/1995
K936068 PELTON & CRANE CO. ORTHOPHOS 3/ ORTHOPHOS 3C 07/29/1994
K833241 PENNWALT CORP. INTREX 10/28/1983
K800063 PENNWALT CORP. XR-710 03/03/1980
K792307 PRECISE OPTICS DENTIX DENTAL X-RAY UNIT 01/09/1980
K934645 RADWORKS CORP. RADWORKS 08/17/1994
K933455 SCHICK TECHNOLOGIES, INC. COMPUTED ORAL RADIOLOGY SYSTEM 01/31/1994
K041385 SCHICK TECHNOLOGIES, INC. MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM 06/07/2004
K093453 SCHICK TECHNOLOGIES, INC. MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM 11/30/2009
K792535 SIEMENS CORP. PORTARAY 01/28/1980
K896963 TEMPO TECHNOLOGY, INC. TRIMODE SP DENTAL INTRA ORAL X-RAY 01/22/1990
K760323 THE S. S. WHITE CO. X-RAY UNIT, DENTAL DIAGNOSTIC 08/03/1976
K770345 THORO-RAY, INC. X-RAY TUBE - "PANOBEAM" 03/08/1977
K953936 TROPHY RADIOLOGIE ATLANTIS 12/28/1995
K950532 TROPHY RADIOLOGIE TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY 04/19/1995
K950533 TROPHY RADIOLOGIE TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY 06/30/1995
K791014 XEROX MEDICAL SYSTEMS DENTAL XERORADIOGRAPHY 09/04/1979


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