Unit, X-Ray, Extraoral With Timer
Regulation 872.1800
6510(k)s in 12 months (191 all time)
0recalls in 12 months (18 all time)
17recalls that name a 510(k)
Top companies in EHD
| Company | 510(k)s | Recalls |
|---|---|---|
| Planmeca Oy | 14 | 0 |
| Digimed Co., Ltd. | 6 | 1 |
| Gendex Dental Systems | 1 | 6 |
| Villa Sistemi Medicali S.P.A. | 7 | 0 |
| Trophy Radiologie | 6 | 0 |
| VATECH Co., Ltd. | 6 | 0 |
| Aribex | 3 | 2 |
| Dentsply Intl. | 4 | 0 |
| Gendex Corp. | 3 | 1 |
| Instrumentarium Corp. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 2014 | K141497 | PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) Osstem Implant Co., Ltd. | EHD |
| May 30, 2014 | K132378 | X-MIND UNITY De Gotzen S.R.L., IT | EHD |
| Aug 1, 2013 | K130109 | ENDOGRAPH DC Villa Sistemi Medicali S.P.A., IT | EHD |
| Jul 31, 2013 | K132041 | REXTAR X Meta Biomed, Inc. | EHD |
| May 16, 2013 | K122124 | PORTABLE X-RAY SYSTEM Osstem Implant Co., Ltd. | EHD |
| Mar 1, 2013 | K122016 | REXTAR, REXTAR LCD Meta Biomed, Inc. | EHD |
| Dec 13, 2012 | K123493 | VEX-S 100W INTRAORAL X-RAY SYSTEM VATECH Co., Ltd. | EHD |
| Dec 7, 2012 | K122582 | DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) Denterprise International, Inc. | EHD |
| May 27, 2011 | K111330 | AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY Skanray Technologies, IN | EHD |
| Apr 8, 2011 | K103600 | PORTABLE X-RAY SYSTEM Digimed Corporation | EHD |
| Mar 18, 2011 | K103579 | INTRA SKAN DC Skanray Technologies, IN | EHD |
| Oct 18, 2010 | K093105 | VISTEO Owandy | EHD |
| May 12, 2010 | K091255 | MINXRAY, MODEL: BPD60 Minxray, Inc. | EHD |
| Mar 22, 2010 | K093240 | BELRAY II Takara Belmont Corp. | EHD |
| Jan 6, 2010 | K092772 | PORTABLE X-RAY SYSTEM, MODEL HAND-RAY Hanjin Digi-X Co., Ltd. | EHD |
| Oct 9, 2009 | K092103 | DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) VATECH Co., Ltd. | EHD |
| Jul 29, 2009 | K091197 | PLANMECA PROSENSOR Planmeca Oy | EHD |
| May 18, 2009 | K090749 | ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 Villa Sistemi Medicali S.P.A., IT | EHD |
| Feb 5, 2009 | K082875 | PORTABLE X-RAY SYSTEM, MODEL DXR -1 Exaro Co., Ltd. | EHD |
| Dec 23, 2008 | K083344 | HELIODENT PLUS Sirona Dental Systems GmbH, DE | EHD |
| Sep 26, 2008 | K082167 | PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX Digimed Corporation | EHD |
| Aug 21, 2008 | K081899 | ANYRAY PORTABLE X-RAY SYSTEM E-Woo Technology Co., Ltd. | EHD |
| Jun 23, 2008 | K081664 | NOMAD PRO X-RAY SYSTEM Aribex, Inc. | EHD |
| Mar 14, 2008 | K080076 | RX DC X-RAY UNIT Cefla S.C.R.L. | EHD |
| Jan 11, 2007 | K063121 | PORTABLE X-RAY SYSTEM, MODEL PORT-X II Genoray Co., Ltd. | EHD |
| Apr 24, 2006 | K060640 | DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM Dentamerica | EHD |
| Mar 3, 2006 | K060292 | KODAK MODELS 2100 AND 2200 Kodak-Trophy, FR | EHD |
| Jul 14, 2005 | K051795 | NOMAD DENTAL X-RAY SYSTEM Aribex, Inc. | EHD |
| Jun 24, 2005 | K051464 | PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) Planmeca Oy | EHD |
| Mar 17, 2005 | K050255 | ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 Gendex Dental Systems | EHD |
| Feb 24, 2005 | K043104 | KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 Practiceworks, Inc. | EHD |
| Feb 9, 2005 | K043612 | ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D Instrumentarium Corp. Imaging Division | EHD |
| Jan 31, 2005 | K050019 | IN EXAM INTRAORAL DENTAL X-RAY SYSTEM Kavo America | EHD |
| Jan 13, 2005 | K043557 | MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS Panoramic Corp. | EHD |
| Jan 6, 2005 | K043136 | ELITY 70 X-RAY Dental X-Ray E.U. | EHD |
| Dec 17, 2004 | K043307 | CRANEX D Soredex Palodex Group OY, FI | EHD |
| Dec 13, 2004 | K043092 | PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 Progeny, Inc. | EHD |
| Sep 7, 2004 | K042260 | PHOT-X II, MODEL 303 Takara Belmont USA, Inc. | EHD |
| Jul 13, 2004 | K040382 | CRANEX BASEX D OR CRANEX EXCEL D Soredex Palodex Group OY, FI | EHD |
| Jun 2, 2004 | K040748 | ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM Takara Belmont USA, Inc. | EHD |
| Apr 29, 2004 | K033755 | MINRAY Soredex Palodex Group OY, FI | EHD |
| Apr 7, 2004 | K040556 | TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY Eastman Kodak Company | EHD |
| Feb 20, 2004 | K033690 | TROPHYPAN AND TROPHYPAN C Trophy Radiologie, FR | EHD |
| Oct 10, 2003 | K033073 | ORTHOPHOS XG DS/CEPH Sirona Dental Systems GmbH | EHD |
| Sep 25, 2003 | K032355 | ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW Dentsply Gendex | EHD |
| Jul 31, 2003 | K031448 | RSV (RADIOLOGY SYSTEM VISIODENT Visiodent SA | EHD |
| Jul 21, 2003 | K031802 | CORIX 70 PLUS-USV Coramex, S.A. | EHD |
| Jul 21, 2003 | K030634 | ENDOS DC Villa Sistemi Medicali S.P.A. | EHD |
| Jul 8, 2003 | K031118 | INTRAOS 70 Blue X Imaging Srl | EHD |
| Apr 16, 2003 | K024285 | A/T X-RAY 70 Air Techniques, Inc. | EHD |
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