FDA 510(k) Applications for Medical Device Product Code "EHD"
(Unit, X-Ray, Extraoral With Timer)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K223780 | 3Dio | Lumos 3DX | 07/06/2023 |
| K030647 | AFP IMAGING CORP. | EVA DIGITAL DENTAL X-RAY SYSTEM | 03/20/2003 |
| K013176 | AFP IMAGING CORP. | MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE | 10/16/2001 |
| K024285 | AIR TECHNIQUES, INC. | A/T X-RAY 70 | 04/16/2003 |
| K173319 | Aribex | KaVo NOMAD Pro 2 Handheld X-ray System | 11/16/2017 |
| K051795 | ARIBEX, INC. | NOMAD DENTAL X-RAY SYSTEM | 07/14/2005 |
| K081664 | ARIBEX, INC. | NOMAD PRO X-RAY SYSTEM | 06/23/2008 |
| K963699 | BELMONT EQUIPMENT CORP. | BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY | 12/23/1996 |
| K031118 | BLUE X IMAGING SRL | INTRAOS 70 | 07/08/2003 |
| K011147 | CAVITAT MEDICAL TECHNOLOGIES, INC. | CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT) | 02/15/2002 |
| K080076 | CEFLA S.C.R.L. | RX DC X-RAY UNIT | 03/14/2008 |
| K163519 | CEFLA SC | RX DC | 01/13/2017 |
| K232068 | Changzhou Sifary Medical Technology Co., Ltd. | HyperLight Portable X-ray Unit | 09/01/2023 |
| K972968 | CHICAGO X-RAY SYSTEMS, INC. | ROTOGRAPH PLUS | 10/08/1997 |
| K031802 | CORAMEX, S.A. | CORIX 70 PLUS-USV | 07/21/2003 |
| K132378 | DE GOTZEN S.R.L. | X-MIND UNITY | 05/30/2014 |
| K043136 | DENTAL X-RAY E.U. | ELITY 70 X-RAY | 01/06/2005 |
| K021378 | DENTALEZ GROUP | PORTABLE HDX INTRAORAL X-RAY | 06/07/2002 |
| K060640 | DENTAMERICA | DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM | 04/24/2006 |
| K122582 | DENTERPRISE INTERNATIONAL, INC. | DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) | 12/07/2012 |
| K180561 | Denterprise International, Inc. | MobileX Portable X-ray System | 04/04/2018 |
| K032355 | DENTSPLY GENDEX | ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW | 09/25/2003 |
| K980543 | DENTSPLY INTL. | DENOPTIX BARRIER ENVELOPE (SIZE 0-4) | 04/14/1998 |
| K992610 | DENTSPLY INTL. | GENDEX 765DC, MODEL 110-0154 | 09/07/1999 |
| K994285 | DENTSPLY INTL. | ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH | 03/14/2000 |
| K964659 | DENTSPLY INTL. | ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM | 12/23/1996 |
| K220579 | Digimed Co., Ltd | Hybrid C70 | 09/01/2022 |
| K221587 | DIGIMED Co., Ltd. | DHX-70H, XTG-70H | 03/03/2023 |
| K220574 | Digimed Co., LTD. | HYBRID S70 | 04/22/2022 |
| K181891 | Digimed Co., LTD. | Portable X-ray System (Model: MiniX-V, Mini X-S) | 08/10/2018 |
| K152859 | DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012) | Portable X-ray System (Model: MINIX-V / MINIX-S) | 12/03/2015 |
| K103600 | DIGIMED CORPORATION | PORTABLE X-RAY SYSTEM | 04/08/2011 |
| K082167 | DIGIMED CORPORATION | PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX | 09/26/2008 |
| K081899 | E-WOO TECHNOLOGY CO., LTD. | ANYRAY PORTABLE X-RAY SYSTEM | 08/21/2008 |
| K973476 | EASTMAN KODAK COMPANY | KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER | 11/10/1997 |
| K040556 | EASTMAN KODAK COMPANY | TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY | 04/07/2004 |
| K221233 | ECOTRON Co., Ltd | DT-703 | 06/27/2022 |
| K965203 | ELECTRO MEDICAL SYSTEMS, INC. | RADX SYSTEM | 03/17/1997 |
| K963185 | ELECTRONIC CONTROL CONCEPTS | ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMER | 10/02/1996 |
| K213282 | Energy Resources International Co., Ltd. Hsinchu Branch | ERI Handheld Dental X-ray System (Model AG100) | 04/04/2022 |
| K082875 | EXARO CO., LTD. | PORTABLE X-RAY SYSTEM, MODEL DXR -1 | 02/05/2009 |
| K962631 | FAIR IMAGE, INC. | DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM | 11/26/1996 |
| K222274 | FONA S.r.l | FONA XDC | 08/23/2022 |
| K050255 | GENDEX DENTAL SYSTEMS | ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 | 03/17/2005 |
| K172810 | GENORAY Co., Ltd. | PORT-X IV | 03/07/2018 |
| K063121 | GENORAY CO., LTD. | PORTABLE X-RAY SYSTEM, MODEL PORT-X II | 01/11/2007 |
| K222569 | Guilin Woodpecker Medical Instrument Co., Ltd. | Ai Ray Dental X-Ray Device | 11/23/2022 |
| K092772 | HANJIN DIGI-X CO., LTD. | PORTABLE X-RAY SYSTEM, MODEL HAND-RAY | 01/06/2010 |
| K190357 | HDX WILL Corp. | Star-X, Intraoral X-ray System | 03/15/2019 |
| K192700 | HDX WILL Corp. | Xcam | 12/27/2019 |
| K001248 | IMAGING SCIENCES INTL., INC. | MULTI-PULSE 2000 | 05/04/2000 |
| K991518 | IMAGING SCIENCES INTL., INC. | PANATOME | 06/18/1999 |
| K962422 | INFIMED, INC. | INFIMED DENTAL SYSTEM | 09/11/1997 |
| K001729 | INSTRUMENTARIUM CORP. | FOCUS | 07/13/2000 |
| K022630 | INSTRUMENTARIUM CORP. | MODIFICATION TO FOCUS | 10/09/2002 |
| K043612 | INSTRUMENTARIUM CORP. IMAGING DIVISION | ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D | 02/09/2005 |
| K973642 | INSTRUMENTARIUM IMAGING, INC. | ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 | 11/21/1997 |
| K984030 | INTEGRA MEDICAL | VIPERSOFT | 02/10/1999 |
| K223010 | iRay Technology Taicang Ltd. | Portable X-ray System | 01/17/2023 |
| K013955 | J. MORITA USA, INC. | VERAVIEWEPOCS, MODEL VE | 02/04/2002 |
| K974077 | J. MORITA USA, INC. | VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS. | 01/20/1998 |
| K050019 | KAVO AMERICA | IN EXAM INTRAORAL DENTAL X-RAY SYSTEM | 01/31/2005 |
| K965072 | KAYCOR INTL., LTD. | PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT | 01/27/1997 |
| K060292 | KODAK-TROPHY | KODAK MODELS 2100 AND 2200 | 03/03/2006 |
| K190935 | Livermoretech Inc. | EZER, Portable X-ray System | 12/19/2019 |
| K000551 | MEDICAL DEVICE CONSULTANTS, INC. | IMAGE X-70 PLUS DENTAL X-RAY UNIT | 03/16/2000 |
| K132041 | META BIOMED, INC. | REXTAR X | 07/31/2013 |
| K122016 | META BIOMED, INC. | REXTAR, REXTAR LCD | 03/01/2013 |
| K000061 | MINXRAY, INC. | MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT | 04/07/2000 |
| K091255 | MINXRAY, INC. | MINXRAY, MODEL: BPD60 | 05/12/2010 |
| K201800 | NANORAY Co., Ltd. | Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) | 12/28/2020 |
| K963403 | NEW IMAGE INDUSTRIES, INC. | ACURAY DIGITAL X-RAY | 01/02/1997 |
| K231449 | Ningbo Runyes Medical Instrument Co., Ltd. | Portable X-ray System Model Ray98(P) | 07/13/2023 |
| K974877 | ORION CORPORATION SOREDEX | CRANEX TOME CEPH, OR CRANEX TOME | 03/27/1998 |
| K122124 | OSSTEM IMPLANT CO.,LTD | PORTABLE X-RAY SYSTEM | 05/16/2013 |
| K141497 | OSSTEM IMPLANT CO.,LTD | PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) | 08/26/2014 |
| K093105 | OWANDY | VISTEO | 10/18/2010 |
| K043557 | PANORAMIC CORP. | MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS | 01/13/2005 |
| K972249 | PELTON & CRANE CO. | ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD | 09/12/1997 |
| K972168 | PELTON & CRANE CO. | SIDEXIS DIGITAL RADIOGRAPHY SYSTEM | 09/05/1997 |
| K000771 | PLANMECA OY | DIMAX 2 | 05/03/2000 |
| K000428 | PLANMECA OY | DIXI 2 | 04/28/2000 |
| K980581 | PLANMECA OY | PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM | 04/17/1998 |
| K051464 | PLANMECA OY | PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) | 06/24/2005 |
| K091197 | PLANMECA OY | PLANMECA PROSENSOR | 07/29/2009 |
| K970263 | PLANMECA OY | PM 2002 CC PROLINE | 02/26/1997 |
| K970812 | PLANMECA OY | PM 2002 CC PROLINE | 08/05/1997 |
| K000163 | PLANMECA OY | PM 2002 PROLINE/AEC | 04/18/2000 |
| K011619 | PLANMECA OY | PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT | 06/29/2001 |
| K970975 | PLANMECA OY | PROSTYLE INTRA | 04/01/1997 |
| K043104 | PRACTICEWORKS, INC. | KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 | 02/24/2005 |
| K020070 | PROGENY, INC. | JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002 | 02/01/2002 |
| K043092 | PROGENY, INC. | PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 | 12/13/2004 |
| K160458 | RADIOTECNOLOGIA INDUSTRIAL S.A. DE C.V. | BI IMAGE-X EVOLUTION | 06/20/2016 |
| K180671 | RHT Co., Ltd | MINE | 06/05/2019 |
| K172928 | Rolence Enterprise Inc. | Portable X-ray System | 03/16/2018 |
| K002062 | SAMSUNG SDS CO., LTD | SAMSUNG 10DR IMPLANT SYSTEM | 11/09/2000 |
| K972921 | SANKO X-RAY MANUFACTURING CO., LTD. | SANKO INTRAORAL DENTAL X-RAY | 01/06/1998 |
| K970850 | SCANRITE SYSTEMS | SCANRITE DFS | 05/14/1997 |
| K972312 | SIEMENS AG | SIEMENS ORTHOPHOS DS/DS CEPH | 09/15/1997 |
| K083344 | SIRONA DENTAL SYSTEMS GMBH | HELIODENT PLUS | 12/23/2008 |
| K000672 | SIRONA DENTAL SYSTEMS GMBH | HELIODENT VARIO | 05/02/2000 |
| K033073 | SIRONA DENTAL SYSTEMS GMBH | ORTHOPHOS XG DS/CEPH | 10/10/2003 |
| K111330 | SKANRAY TECHNOLOGIES | AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY | 05/27/2011 |
| K103579 | SKANRAY TECHNOLOGIES | INTRA SKAN DC | 03/18/2011 |
| K170967 | Skanray Technologies Private Limited | Intraskan DC Plus | 06/08/2017 |
| K040382 | SOREDEX PALODEX GROUP OY | CRANEX BASEX D OR CRANEX EXCEL D | 07/13/2004 |
| K043307 | SOREDEX PALODEX GROUP OY | CRANEX D | 12/17/2004 |
| K033755 | SOREDEX PALODEX GROUP OY | MINRAY | 04/29/2004 |
| K962120 | STERI-OSS, INC. | TOMOGRAPH ACCESSORIES | 07/25/1996 |
| K211014 | Surround Medical Systems | Portray | 07/28/2021 |
| K093240 | TAKARA BELMONT CORP. | BELRAY II | 03/22/2010 |
| K141293 | TAKARA BELMONT CORPORATION | PHOT-X IIS MODEL 505 | 09/03/2014 |
| K040748 | TAKARA BELMONT USA, INC. | ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM | 06/02/2004 |
| K042260 | TAKARA BELMONT USA, INC. | PHOT-X II, MODEL 303 | 09/07/2004 |
| K012355 | TG GROUP, INC. | IMAGE-X SYSTEM | 08/09/2001 |
| K021245 | THE GOTZEN GROUP, INC. | DEGOTZEN SYNCHRO | 05/03/2002 |
| K182206 | Trident s.r.l | RiX70 DC | 09/13/2018 |
| K961826 | TROPHY RADIOLOGIE | DIGIPAN | 09/23/1996 |
| K962337 | TROPHY RADIOLOGIE | ELITYS OR ELITYS-E | 07/25/1996 |
| K991912 | TROPHY RADIOLOGIE | MODIFICATION TO DIGIPAN | 06/22/1999 |
| K991455 | TROPHY RADIOLOGIE | ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, | 06/25/1999 |
| K033690 | TROPHY RADIOLOGIE | TROPHYPAN AND TROPHYPAN C | 02/20/2004 |
| K161063 | Vatech Co., Ltd | EzRay Air (Model VEX-P300) | 09/01/2016 |
| K223058 | Vatech Co., Ltd | EzRay Air 2 Wall (Model: VEX-S350W) | 10/26/2022 |
| K200182 | Vatech Co., Ltd | EzRay Air Portable (Model: VEX-P300) | 02/11/2020 |
| K163705 | Vatech Co., Ltd | EzRay Air W | 01/24/2017 |
| K092103 | VATECH CO., LTD. | DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) | 10/09/2009 |
| K123493 | VATECH CO., LTD. | VEX-S 100W INTRAORAL X-RAY SYSTEM | 12/13/2012 |
| K984524 | VILLA SISTEMI MEDICALI S.P.A. | AZTECH 70 | 01/14/1999 |
| K130109 | VILLA SISTEMI MEDICALI S.P.A. | ENDOGRAPH DC | 08/01/2013 |
| K030185 | VILLA SISTEMI MEDICALI S.P.A. | ENDOS AC/ACP | 03/11/2003 |
| K030634 | VILLA SISTEMI MEDICALI S.P.A. | ENDOS DC | 07/21/2003 |
| K991310 | VILLA SISTEMI MEDICALI S.P.A. | EXPLOR-X 70 | 06/18/1999 |
| K090749 | VILLA SISTEMI MEDICALI S.P.A. | ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 | 05/18/2009 |
| K002432 | VILLA SISTEMI MEDICALI S.P.A. | STRATO X | 09/01/2000 |
| K031448 | VISIODENT SA | RSV (RADIOLOGY SYSTEM VISIODENT | 07/31/2003 |
| K221286 | VSI Co., Ltd. | CLAROX | 06/29/2022 |
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