FDA 510(k) Applications for Medical Device Product Code "MUH"
(System,X-Ray,Extraoral Source,Digital)

FDA 510(k) Number Applicant Device Name Decision Date
K131442 3DISC AMERICAS FIRECR DENTALIMAGING SYSTEM 09/06/2013
K041120 AFP IMAGING CORP. EV APAN DIGITAL, MODEL K1VSM2000 08/30/2004
K123419 AFP IMAGING CORP. EVA SELECT DIGITAL DENTAL IMAGING SYSTEM 12/27/2012
K072357 AFP IMAGING CORP. NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM 09/18/2007
K021542 AGFA CORP. ADC DENTAL 08/06/2002
K050693 AIR TECHNIQUES, INC. ACCENT 05/26/2005
K013893 AIR TECHNIQUES, INC. SCANX 02/01/2002
K191623 Air Techniques, Inc. ScanX Touch/ScanX Duo Touch 08/21/2019
K230732 Alliage S/A Industrias Medica Odontol≤gico. Eagle S/Saevo Slim/D700 Slim 04/11/2023
K120106 APIXIA INC. APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM 05/07/2012
K211688 Athlos Oy DC-Air and Athlos-1 and Athlos-Air 07/22/2021
K031801 BLUE X IMAGING SRL PANTOS, MODELS: PANTOS 16, AND PANTOS DG 09/11/2003
K010915 CAMSIGHT CO., INC. CDMX 05/21/2001
K053221 CAMSIGHT CO., INC. CDMX-H 01/12/2006
K111649 CARESTREAM HEALTH, INC. CS 7600 09/23/2011
K101661 CEFLA DENTAL GROUP MYRAY HYPERION 09/16/2010
K100960 CEFLA DENTAL GROUP WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS 10/21/2010
K081088 CEFLA S.C. MYRAY SKYVIEW 11/06/2008
K152162 CEFLA S.C. Myray- HYPERION X5 12/24/2015
K113497 CEFLA S.C. CEFLA DENTAL GROUP HYPERION 01/17/2012
K061114 CEFLA S.C.R.L. WDS, SIZE 2 AND SIZE 2 06/06/2006
K033147 CLEARTOOTH ELECTRONICS, INC. CLEARTOOTH DIGITAL X-RAY SYSTEM 12/30/2003
K042736 CNC IMAGING, INC. CDX DIGITAL X-RAY IMAGING SYSTEM 10/13/2004
K190234 CND Global Technologies, Inc. ODI HD Dental Sensor 03/01/2019
K183637 Cruxell Corp. Cruxcan (CRX-1000) 02/12/2019
K211317 CRUXELL Corp. CRUXVIEW 07/29/2021
K203374 de G÷tzen S.r.l. X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) 02/05/2021
K191719 de Gotzen S.R.L X-MIND Trium 02/20/2020
K990087 DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. DMD DIGITAL X-RAY SYSTEM 05/13/1999
K231202 Denterprise International Inc. QuickRayPRO 06/22/2023
K151926 DENTERPRISE INTERNATIONAL, INC. QuickRay HD Intraoral Sensor 12/14/2015
K092547 DENTIMAX DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX 10/30/2009
K220556 DentiMax, Inc OpenSensorX Series 04/13/2022
K153144 DENTTIO, INC. TIO-H DIGITAL RADIOGRAPHY SENSOR 02/10/2016
K070811 DEXCO CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 07/05/2007
K083532 DEXCOWIN CO., LTD ADX4000-L, DX3000-L 03/10/2009
K134055 DEXCOWIN CO., LTD ADX4000W 05/09/2014
K133007 DEXCOWIN CO., LTD DX3000-L 04/24/2014
K173046 Dexcowin Co., Ltd. Cocoon Portable Handheld X-Ray System 10/26/2017
K090458 DEXIS LLC DEXIS SENSOR 05/28/2009
K990049 DIGIDENT LTD. CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 2000 03/12/1999
K202633 Dⁿrr Dental SE ScanX Edge 10/07/2020
K013271 DOUGLAS C. YOON, DDS DXS DIGITAL X-RAY SYSTEM 12/13/2001
K170733 Duerr Dental AG ScanX Intraoral View 05/01/2017
K230095 Durr Dental SE ScanX Swift 2.0, ScanX Swift View 2.0 02/06/2023
K203116 Durr Dental SE SensorX 03/19/2021
K090526 E-WOO TECHNOLOGY MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR 12/02/2009
K060079 EASTMAN KODAK COMPANY KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM 02/08/2006
K103290 EDLEN IMAGING LLC EDLEN IMAGING - GEMINI DUSB 09/19/2011
K150823 EDLEN IMAGING LLC EDLENi Intra-Oral Sensor 08/26/2015
K020588 ESCAPE TECHNOLOGY, INC. X-IMAGE DIGITAL X-RAY SYSTEM 06/13/2002
K212103 FONA S.r.l StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 08/30/2021
K161131 FONA SRL FONA Pan/Ceph 11/03/2016
K192766 Fsusen Technology Co., Ltd Digital Intraoral Imaging Plate System 12/05/2019
K060178 GENDEX DENTAL SYSTEMS VIX WIN PRO 03/10/2006
K232158 Genoray Co., Ltd. GenX-CR 09/13/2023
K220423 GENORAY Co., Ltd. PAPAYA & PAPAYA Plus 05/19/2022
K130419 GENORAY CO., LTD. PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM 11/06/2013
K141700 GENORAY CO., LTD. PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM 10/31/2014
K130088 GENORAY CO., LTD. PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM 07/18/2013
K120263 GENORAY CO., LTD. VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM 07/10/2012
K092171 GENORAY CO., LTD. VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM 04/26/2010
K212080 Guilin Woodpecker Medical Instrument Co., Ltd. Imaging Plate Scanner, i-Scan 09/27/2021
K181297 HDX WILL CORP. DENTIOIII series (DENTIOIII, DENTIOIII-S) 11/21/2018
K214091 Hefei DentaFilm Medical Equipment Co., Ltd Dental Image Plate Scanner, Model DFC-4T-SMART 03/02/2022
K041580 HENRY SCHEIN, INC. IMAGERAYI 06/29/2004
K033248 HITACHI MEDICAL SYSTEMS AMERICA, INC. HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM 10/20/2003
K061284 IMAGING SCIENCES INTL., INC. I-CAT SCANNER 07/03/2006
K992392 INFIMED, INC. RTLX 03/31/2000
K001439 INSTRUMENTARIUM CORP. ORTHOCEPH OC100 D 06/22/2000
K992385 INSTRUMENTARIUM CORP. ORTHOPANTOMOGRAPH OP100D 09/28/1999
K133231 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY DIGORA OPTIME 03/20/2014
K092591 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY ORTHOPANTOMOGRAPH OP30 11/20/2009
K093683 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY ORTHOPANTOMOGRAPH OP300 10/06/2010
K063837 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY SIGMA M 07/02/2007
K081925 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY SNAPSHOT 09/02/2008
K001928 INSTRUMENTARIUM IMAGING, INC. SIGMA 08/02/2000
K230811 iRay Imaging Technology (Haining) Limited Digital Intraoral X-Ray Sensor 04/21/2023
K220422 iRay Technology Taicang Ltd. Dental sensors NanoPix1, NanoPix2 03/11/2022
K212279 iRay Technology Taicang Ltd. Digital Intraoral X-ray Imaging System 10/07/2021
K210312 iRay Technology Taicang Ltd. PlutoX Digital Intraoral X-Ray Imaging System 04/23/2021
K053220 J. MORITA USA, INC. VERAVIEW IC 5, MODEL XDP1 01/06/2006
K073696 J. MORITA USA, INC. VERAVIEWEPOCS 04/08/2008
K163224 Jazz Imaging LLC JAZZ SOLO Sensor 03/09/2017
K213637 Jazz Imaging LLC dba JAZZ Imaging JAZZ Solo sensor 12/10/2021
K990002 JULIE ALLIANCE QUICKRAY DSX 730 04/01/1999
K172918 KaVo Dental Technologies, LLC DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) 12/18/2017
K023292 KRUGMAN TECHNOLOGIES, INC APEX HRI DIGITAL RADIOGRAPHY SYSTEM 12/13/2002
K163282 Masterlink LLC Apex Dental Sensors 02/28/2017
K122806 MIC INTERNATIONAL IMAGE WORKS PANOURA 03/08/2013
K091866 MIDMARK PROGENY VANTAGE PANORAMIC X-RAY SYSTEM 07/20/2009
K112380 MIDMARK CORP. CLEARVISION 11/22/2011
K122643 MIDMARK CORP. VANTAGE MODEL V5000, V5100, V5000C, V5100C 01/07/2013
K002425 MULTI MEDIA DENTAL SYSTEMS, INC. MEDIADENT HDX/MMD HDX SP XRAY SENSOR 12/21/2000
K143703 NICAL SPA NICAL SMART MICRO CR system for intraoral dental images 03/18/2015
K983267 ORION CORPORATION SOREDEX DIGORA FOR WINDOWS 2.0 12/30/1998
K083057 OWANDY I-MAX TOUCH 06/02/2009
K062403 OWANDY IMAX CEPH DIGITAL X-RAY SENSOR 11/14/2006
K070505 OWANDY KRYSTAL-X WIFI 04/05/2007
K133271 OWANDY OPTEO, VIDEOGRAPH HD 04/28/2014
K053172 OWANDY SAS UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) 06/09/2006
K051664 OY AJAT, LTD. SCAN300FP / RETROPAN (VDC) 07/20/2005
K173646 PaloDEx Group Oy FS Ergo 12/19/2017
K141130 PANORAMIC CORP. ENCOMPASS 07/30/2014
K110371 PANORAMIC CORP. ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY 03/17/2011
K000454 PLANMECA OY DIMEX 2 03/31/2000
K060328 PLANMECA OY PLANMECA PROMAX 3D 03/15/2006
K093590 PLANMECA OY PLANMECA PROMAX 3D MAX 05/12/2010
K103689 PLANMECA OY PLANMECA PROMAX 3D MID 03/17/2011
K072244 PLANMECA OY PLANMECA PROONE 09/21/2007
K121800 POINTNIX CO., LTD POINT 500 HD POINT500C HD 01/24/2013
K070664 PROGENY, INC. PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8). 04/26/2007
K041831 PROGENY, INC. PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR 08/09/2004
K232255 Qpix Solutions Inc. EZSensor XHD 09/27/2023
K131693 RAY CO., LTD RAYSCAN A-EXPERT 11/01/2013
K142058 RAY CO., LTD RAYSCAN A-EXPERT 04/22/2015
K122918 RAY CO., LTD RAYSCAN A-EXPERT 03/15/2013
K160788 RAY CO., Ltd RIOScan (RPS500) 04/15/2016
K153060 RAYENCE CO., LTD Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S 11/10/2015
K150797 Rayence Co., Ltd Digital Dental Intra Oral Sensor, EzSensor Smart 05/01/2015
K143753 Rayence Co., Ltd Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio 03/10/2015
K151707 RAYENCE CO., LTD EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i 07/19/2015
K221955 RealCloud Imaging Inc. dba RealCloud Imaging Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 08/31/2022
K200284 Remedi Co. Ltd. R-Sensor, R-Sensor 02/28/2020
K111103 RF CO., LTD DIGITAL X-RAY IMAGING SYSTEM 01/05/2012
K202369 Rolence Enterprise Inc. RXS 1000 09/15/2021
K031291 SCHICK TECHNOLOGIES, INC. CDR PANX, MODEL 4792 05/05/2003
K053558 SCHICK TECHNOLOGIES, INC. CEPH, MODEL 4900 02/17/2006
K110768 SCHICK TECHNOLOGIES, INC. COMPUTED DENTAL RADIOGRAPHY 04/20/2011
K022953 SCHICK TECHNOLOGIES, INC. MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM 10/02/2002
K072134 SCHICK TECHNOLOGIES, INC. SCHICK COMPUTED ORAL RADIOLOGY SYSTEM 11/02/2007
K221008 Shanghai Handy Medical Equipment Co., Ltd HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) 06/22/2022
K220277 Shenzhen Xpectvision Technology Co.,Ltd. Digital Intraoral X-ray Sensor 02/17/2022
K060179 SIGMA BIOMEDICS, INC. BIO-RAY SDX DIGITAL X-RAY SYSTEM 02/08/2006
K983283 SIGNET RADIOLOGY, INC. SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM 11/06/1998
K060892 SIRONA DENTAL SYSTEMS GMBH GALILEOS 04/14/2006
K013659 SIRONA DENTAL SYSTEMS GMBH MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM 12/06/2001
K990528 SIRONA DENTAL SYSTEMS GMBH ORTHOPHOS 3/3 CEPH/3 DS 04/30/1999
K983057 SIRONA DENTAL SYSTEMS GMBH ORTHOPHOS 5/PLUS/CD 10/22/1998
K013650 SIRONA DENTAL SYSTEMS GMBH ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD 12/06/2001
K992644 SIRONA DENTAL SYSTEMS GMBH SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM 08/23/1999
K081903 SIRONA DENTAL SYSTEMS GMBH XIOS PLUS WALL-MODULE 08/26/2008
K181636 Sodium Systems, LLC Aurora 07/20/2018
K024186 SOMETECH CORPORATION X-VIEW 04/01/2004
K092329 SOPRO SOPIX 2 07/20/2010
K151053 SOPRO - ACTEON GROUP PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner 07/31/2015
K142995 SOPRO - ACTEON GROUP SOPIX 08/17/2015
K140013 SOPRO - ACTEON GROUP SOPIX INSIDE, SOPIX2 INSIDE 09/05/2014
K063459 SOREDEX PALODEX GROUP OY CRANEX NOVUS 12/26/2006
K041050 SOREDEX PALODEX GROUP OY DIGORA OPTIME (OR DIGORA ONTIME) 06/15/2004
K012170 SOREDEX PALODEX GROUP OY DIGORA PCT 08/10/2001
K070304 SOREDEX PALODEX GROUP OY DIGORA PCT/DIGIPOD 03/27/2007
K073350 SOREDEX PALODEX GROUP OY SCANORA 3D 12/19/2007
K202664 Sota Precision Optics, Inc. dba SOTA Imaging Clio Prime and Clio Pedo 11/06/2020
K021718 SUNI IMAGING MICROSYSTEMS, INC. INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY 08/15/2002
K162585 Suni Medical Imaging, Inc SuniIQ Digital Radiography System 11/04/2016
K060149 SUNI MEDICAL IMAGING, INC. SUNIPAN IMAGING SYSTEM & ACCESSORIES 02/03/2006
K070219 SUNI MEDICAL IMAGING, INC. SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM 02/07/2007
K110160 TAKARA BELMONT CORPORATION BEL-CYPHER N 02/17/2011
K163175 Takara Belmont Corporation Bel-Cypher Pro 03/20/2017
K041834 TAKARA BELMONT USA, INC. ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM 12/03/2004
K062529 TAKARA BELMONT USA, INC. BELMAX CM MODEL X168 10/05/2006
K102456 TAKARA BELMONT USA, INC. INTRAORAL BELSENSOR GOLD 12/15/2011
K090020 TAKARA-BELMONT CO., LTD. BEL-CYPHER, MODEL Y977 03/13/2009
K181358 Televere Systems, Inc. Televere Digital Dental Imaging System 06/20/2018
K111231 THE YOSHIDA DENTAL MFG. CO., LTD. PANOURA 18S 07/13/2011
K182198 The Yoshida Dental Mfg. Co., Ltd. Panoura X-ERA PF/NF/MF 01/31/2019
K092537 TOSHIBA AMERICA ELECTRONIC COMPONENTS, INC. DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540 08/27/2009
K200625 Trident s.r.l I-View Gold and Imagen Gold Dental Sensors 04/15/2020
K160386 TRIDENT S.R.L ReadeR, VieweR, QuickScan PSP 03/10/2016
K162619 TRIDENT S.R.L. I View and Imagen Sensor 11/04/2016
K120975 TROPHY CS 8100 CS 8100 ACCESS 06/22/2012
K151087 TROPHY CS 8100SC, CS8100SC Access 08/21/2015
K073435 TROPHY KODAK 9000, KODAK 9000 3D 02/11/2008
K080889 TROPHY KODAK 9000C EXTRAORAL IMAGING SYSTEM 04/29/2008
K082972 TROPHY KODAK 9500 12/05/2008
K093478 TROPHY KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM 04/26/2010
K012514 TROPHY RADIOLOGIE DIGIPAN / DPI 12/21/2001
K023346 TROPHY RADIOLOGIE TROPHYPAN 01/03/2003
K170731 Vatech Co., Ltd System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight 04/04/2017
K102124 VATECH CO., LTD. DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM 10/22/2010
K073365 VATECH CO., LTD. DENTAL DIGITAL X-RAY IMAGING SYSTEM 04/08/2008
K100317 VATECH CO., LTD. DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO 03/24/2010
K113672 VATECH CO., LTD. PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM 03/27/2012
K122155 VATECH CO., LTD. PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM 09/04/2012
K130585 VATECH CO., LTD. PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM 07/15/2013
K042372 VATECH VALUE ADDED TECHNOLOGY CO., LTD HDS INTRA-ORAL IMAGING SYSTEM 10/04/2004
K070535 VIDEO DENTAL CONCEPTS, INC. RETROPAN CCD-TWAIN-USB 04/24/2007
K111152 VILLA SISTEMI MEDICALI S.P.A. ROTOGRAPH EVO 3D 07/22/2011
K162190 VILLA SISTEMI MEDICALI S.P.A. Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) 07/06/2017
K120318 VIVI S.R.L. VIVI ERGON-X HF 03/06/2012
K993958 X-CEL X-RAY CORP. IDX-60 INTRAORAL X-RAY 02/14/2000
K133206 ZUMA DENTAL, LLC Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM 05/13/2014


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