Unit, X-Ray, Intraoral
Regulation 872.1810
0510(k)s in 12 months (42 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in EAP
| Company | 510(k)s | Recalls |
|---|---|---|
| Belmont Equipment Corp. | 5 | 0 |
| Trophy Sas | 0 | 4 |
| Chicago X-Ray Systems, Inc. | 2 | 1 |
| Keystone X-Ray, Inc. | 3 | 0 |
| Pelton & Crane Co. | 3 | 0 |
| Schick Technologies, Inc. | 3 | 0 |
| Trophy Radiologie | 3 | 0 |
| General Electric Co. | 2 | 0 |
| Pennwalt Corp. | 2 | 0 |
| Advanced Image Science, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 7, 2012 | K113360 | MEDICAL IMAGE PROCESSING UNIT Humanray Co,Ltd | EAP |
| Jun 30, 2011 | K102573 | PROVU (TM) DENTAL X-RAY SYSTEM Advanced Image Science, Inc. | EAP |
| Nov 30, 2009 | K093453 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM Schick Technologies, Inc. | EAP |
| May 13, 2008 | K080738 | DENTRON SENSOR Dentron Systems, LLC | EAP |
| Sep 27, 2005 | K052422 | THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) Flow X-Ray Corp. | EAP |
| Jun 7, 2004 | K041385 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM Schick Technologies, Inc. | EAP |
| Mar 29, 1996 | K960819 | HELIODENT DS Pelton & Crane Co. | EAP |
| Mar 1, 1996 | K960028 | ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM Dentsply Intl. | EAP |
| Dec 28, 1995 | K953936 | ATLANTIS Trophy Radiologie, FR | EAP |
| Oct 27, 1995 | K954565 | EXPLOR-X (AZTEH) HF Chicago X-Ray Systems, Inc. | EAP |
| Jul 20, 1995 | K951734 | LUMIX 70B Emix U.S.A., Inc. | EAP |
| Jun 30, 1995 | K950533 | TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY Trophy Radiologie, FR | EAP |
| Apr 19, 1995 | K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY Trophy Radiologie, FR | EAP |
| Apr 6, 1995 | K950667 | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER Chicago X-Ray Systems, Inc. | EAP |
| Feb 3, 1995 | K950030 | HELIODENT MD Pelton & Crane Co. | EAP |
| Aug 17, 1994 | K934645 | RADWORKS Radworks Corp. | EAP |
| Jul 29, 1994 | K936068 | ORTHOPHOS 3/ ORTHOPHOS 3C Pelton & Crane Co. | EAP |
| Jan 31, 1994 | K933455 | COMPUTED ORAL RADIOLOGY SYSTEM Schick Technologies, Inc. | EAP |
| Nov 23, 1993 | K931486 | INTREX VSK INTERORAL DENTAL X-RAY UNIT Keystone X-Ray, Inc. | EAP |
| Sep 20, 1993 | K931717 | YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY Kaycor Intl., Ltd. | EAP |
| Jul 13, 1993 | K930925 | INTREX INTERORAL DENTAL X-RAY UNIT Keystone X-Ray, Inc. | EAP |
| May 25, 1993 | K930761 | IMAGE-X 70 INTRAORAL X-RAY SYSTEM Afp Imaging Corp. | EAP |
| Jan 21, 1993 | K923307 | HEALTHPAK X-RAY SOX BARRIERS Healthpak, Inc. | EAP |
| May 23, 1990 | K900681 | PANORAMIC MODEL X-CALIBER X-RAY Belmont Equipment Corp. | EAP |
| Jan 22, 1990 | K896963 | TRIMODE SP DENTAL INTRA ORAL X-RAY Tempo Technology, Inc. | EAP |
| Jan 22, 1990 | K896024 | MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE Mdt Diagnostic Co. | EAP |
| Dec 21, 1988 | K883354 | VARIABLE KV INTREX VSK 60 - 90 KVP Keystone X-Ray, Inc. | EAP |
| Sep 9, 1988 | K882379 | MINIM-X 2001-CIAS & MINIM-X 2002-CIAS Dentomar, Inc. | EAP |
| Apr 24, 1986 | K861328 | NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY Belmont Equipment Corp. | EAP |
| Jun 5, 1985 | K852019 | BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD Belmont Equipment Corp. | EAP |
| Dec 29, 1983 | K834279 | ACURAY 071A DENTAL INTRAORAL X-RAY Belmont Equipment Corp. | EAP |
| Oct 28, 1983 | K833241 | INTREX Pennwalt Corp. | EAP |
| Sep 12, 1983 | K832065 | ACURACY 071, DENTAL, INTRAORAL-X-RAY Belmont Equipment Corp. | EAP |
| Mar 3, 1980 | K800063 | XR-710 Pennwalt Corp. | EAP |
| Jan 28, 1980 | K792535 | PORTARAY Siemens Corp. | EAP |
| Jan 9, 1980 | K792437 | RAFLEX 70 Mdt Corp., Inc. | EAP |
| Jan 9, 1980 | K792307 | DENTIX DENTAL X-RAY UNIT Precise Optics | EAP |
| Sep 4, 1979 | K791014 | DENTAL XERORADIOGRAPHY Xerox Medical Systems | EAP |
| Dec 4, 1978 | K781630 | GE-700 INTRA ORAL X-RAY SYSTEM General Electric Co. | EAP |
| Dec 22, 1977 | K772184 | X-RAY SYSTEM FOR DENTAL APPLICATION General Electric Co. | EAP |
| Mar 8, 1977 | K770345 | X-RAY TUBE - PANOBEAM Thoro-Ray, Inc. | EAP |
| Aug 3, 1976 | K760323 | X-RAY UNIT, DENTAL DIAGNOSTIC The S. S. White Co. | EAP |
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