510(k) clearances for X-ray, Tomography, Computed, Dental
135 on file
- Hefei Meyer Optoelectronic Technology, Inc.Jul 23, 2026
K261748 · Dental Cone-beam Computed Tomography (mDX-15P Series)
- Changzhou Boen Zhongding Medical Technology Co., Ltd.Jun 11, 2026
K250839 · Dental X-ray System
- Yofo Medical Technology Co., Ltd.Jun 4, 2026
K260662 · Dental Cone Beam Computed Tomography System
- medXion Technologies, Inc.May 15, 2026
K253935 · medXion NEXUS
- Ray Co., Ltd.Apr 9, 2026
K260462 · RCT800
- VATECH Co., Ltd.Mar 31, 2026
K260093 · Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
- Cefla S.C.Mar 10, 2026
K252353 · myray ProXIma X6
- Dentsply SironaFeb 5, 2026
K253959 · Primevision 3D
- Ray Co., Ltd.Nov 25, 2025
K251798 · RCT700
- Fussen Technology Co., Ltd.Nov 13, 2025
K251842 · Dental Computed Tomography X-ray System
- Genoray Co., Ltd.Oct 8, 2025
K250060 · GT300; GT300-C
- Yian Medical Technology (Haining) Co., Ltd.Jun 27, 2025
K251642 · Dental CBCT X-ray System
- Yofo Medical Technology Co., Ltd.Apr 17, 2025
K243337 · Dental Cone Beam Computed Tomography System
- Ray Co., Ltd.Mar 12, 2025
K243903 · RCT600
- VATECH Co., Ltd.Feb 21, 2025
K243088 · Green X 12 SE (PHT-40CHS)
- VATECH Co., Ltd.Feb 14, 2025
K243081 · Green X 21 (PHT-90CHO)
- Changzhou Finno Medical Technology Co., Ltd.Jan 9, 2025
K242805 · Dental Cone-beam Computed Tomography (FinScan F350)
- Palodex Group OYSep 12, 2024
K241249 · Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)
- Osstem Implant Co., Ltd.Sep 6, 2024
K233806 · T2 Plus
- Yian Medical Technology (Haining) Co., Ltd.Apr 25, 2024
K240855 · Dental Cone-beam Computed Tomography
- Yian Medical Technology (Haining) Co., Ltd.Jan 9, 2024
K232710 · Dental Cone-beam Computed Tomography
- Planmeca OyDec 28, 2023
K230985 · Planmeca Viso
- Dentium Co., Ltd (Ict Branch)Dec 14, 2023
K231181 · bright CT
- Durr Dental SESep 14, 2023
K232487 · Provecta 3D Prime and Provecta 3D Prime Ceph
- Prexion CorporationSep 8, 2023
K232166 · PreXion3D Expedition
- Ray Co., Ltd.Aug 31, 2023
K232287 · RAYSCAN a-Expert3D
- VATECH Co., Ltd.Jul 19, 2023
K231796 · Grreen X 12 (Model: PHT-75CHS)
- Trident S.R.LJul 10, 2023
K222666 · X-View 3D Pan/X-View 2D Pan
- Palodex Group OYJun 9, 2023
K230505 · Orthopantomograph OP 3D LX
- Ray Co., Ltd.Apr 11, 2023
K230753 · RCT800
- Alliage S/A Industrias Medico OdontológicaApr 7, 2023
K223816 · Dental CT Scanner AXR
- Cefla S.C.Jan 17, 2023
K223794 · hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
- Prexion CorporationJan 12, 2023
K222150 · PreXion3D Expedition
- Megagen Implant Co., Ltd.Dec 6, 2022
K222219 · R2 Studio Q/RCT820
- Prexion CorporationJul 22, 2022
K221525 · PreXion3D Explorer PRO
- Genoray Co., Ltd.May 19, 2022
K220392 · PAPAYA 3D & PAPAYA 3D Plus
- Planmed OYApr 28, 2022
K213278 · Planmed Verity
- Fona S.R.LMar 2, 2022
K213579 · Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
- Cefla S.C.Jan 20, 2022
K214084 · hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
- Hdx Will Corp.Dec 30, 2021
K211159 · eco-x Series (eco-x, eco-x-s)
- Ray Co., Ltd.Nov 29, 2021
K213226 · RCT700
- Hdx Will Corp.Oct 19, 2021
K212254 · DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
- Osstem Implant Co., Ltd.Sep 21, 2021
K212303 · T2
- Alliage S/A Industrias Medico OdontológicaAug 10, 2021
K210820 · EAGLE EDGE AXR90 and AXR120
- Dentium Co., Ltd (Ict Branch)Apr 16, 2021
K200270 · rainbow MCT
- Dentium Co., Ltd (Ict Branch)Apr 16, 2021
K200271 · rainbow CT
- Prexion CorporationFeb 23, 2021
K203784 · PreXion3D Explorer PRO
- VATECH Co., Ltd.Feb 18, 2021
K210329 · Green X 18(Model : PHT-75CHS)
- J. Morita USA, Inc.Feb 18, 2021
K201378 · 3D Accuitomo 150N
- VATECH Co., Ltd.Jan 25, 2021
K203797 · vatech A9 (Model : PHT-30CSS)
- De Gotzen S.R.L.Nov 18, 2020
K201382 · X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
- VATECH Co., Ltd.Oct 27, 2020
K201627 · Dental Computed Tomography X-Ray System, Green X
- Genoray Co., Ltd.Sep 16, 2020
K200469 · PAPAYA 3D Premium & PAPAYA 3D Premium Plus
- Midmark CorporationAug 6, 2020
K201667 · Midmark Extraoral Imaging System (EOIS)
- Dentsply SironaJun 22, 2020
K201140 · Axeos
- Cefla S.C.Apr 9, 2020
K200688 · hyperion X5, NewTom GO, X-RADiUS COMPACT
- Prexion CorporationApr 9, 2020
K193329 · PreXion3D Explorer EX
- TrophyMar 13, 2020
K200183 · CS 9600
- Durr Dental SEMar 5, 2020
K193139 · ProVecta 3D Prime Ceph
- Ray Co., Ltd.Oct 22, 2019
K192737 · RCT800
- Epica International, Inc.Sep 20, 2019
K190856 · SeeFactorCT3
- Osstem Implant Co., Ltd.Aug 30, 2019
K183475 · T1-CS, T1-C
- Dentsply SironaJul 16, 2019
K191616 · Orthophos S
- Cefla S.C.Apr 24, 2019
K190496 · hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
- Ray Co., Ltd.Apr 24, 2019
K190812 · RAYSCAN a-Expert3D
- Prexion CorporationApr 15, 2019
K190320 · PreXion3D Explorer
- Ray Co., Ltd.Dec 14, 2018
K182805 · RCT800
- Planmed OYNov 30, 2018
K180918 · Planmed Verity
- Villa Sistemi Medicali S.P.A.Nov 2, 2018
K180601 · Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
- Ray Co., Ltd.Oct 16, 2018
K182614 · RCT700
- Planmeca OySep 13, 2018
K181576 · Planmeca Viso
- Prexion CorporationAug 17, 2018
K181983 · PreXion 3D Excelsior
- Durr Dental SEAug 2, 2018
K181432 · ProVectra 3D Prime with VistaSoft
- Ray Co., Ltd.Jul 27, 2018
K181452 · RCT800
- Palodex Group OYJun 7, 2018
K180947 · Orthopantomograph OP 3D
- TrophyMay 24, 2018
K181136 · CS 9600
- Prexion CorporationJan 19, 2018
K173878 · PreXion3D Excelsior
- J. Morita USA, Inc.Dec 19, 2017
K171012 · Veraview X800
- Palodex Group OYAug 31, 2017
K163423 · Orthopantomograph OP300
- VATECH Co., Ltd.Jun 16, 2017
K170066 · Green16/Green18 (Model: PHT-65LHS)
- Palodex Group OYApr 7, 2017
K170813 · ORTHOPANTOMOGRAPH OP 3D
- Cefla S.C.Dec 9, 2016
K161900 · HYPERION X5
- De Gotzen S.R.L.Nov 15, 2016
K160166 · X-MIND trium
- Imaging Sciences InternationalNov 10, 2016
K162085 · i-CAT FLX V series / KaVo 3D eXam+ V series
- VATECH Co., Ltd.Oct 28, 2016
K160882 · PaX-i3D Green Premium (Model: PCT-90LH)
- VATECH Co., Ltd.Oct 20, 2016
K162660 · Green Smart (Model: PHT-35LHS)
- Prexion CorporationOct 3, 2016
K161881 · PreXion3D Excelsior
- Hdx Will Corp.Sep 30, 2016
K160140 · DENTRIa series
- Ray Co., Ltd.Jun 20, 2016
K160525 · RCT700
- Edlen Imaging, LLCJun 7, 2016
K151137 · X-VIEW, IMAGEN
- Planmeca OyMay 20, 2016
K160506 · Planmeca ProMax 3D Max, Planmeca Maximity
- Qr S.R.L.Mar 31, 2016
K151612 · NewTom VGi evo
- Panoramic Corp.Feb 4, 2016
K152489 · ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
- Genoray Co., Ltd.Dec 10, 2015
K150354 · PAPAYA 3D Plus
- VATECH Co., Ltd.Oct 23, 2015
K152106 · Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
- Planmed OYMay 14, 2015
K143435 · Planmed Verity
- Sirona Dental Systems GmbHMay 8, 2015
K150217 · ORTHOPHOS SL
- Ray Co., Ltd.Apr 17, 2015
K142247 · RAYSCAN A-EXPERT 3D
- Telesystems Co., Ltd.Sep 4, 2014
K133797 · QMASTER-H/REVO
- VATECH Co., Ltd.Aug 7, 2014
K132983 · TON-95LH, PAX-I3D ORTHO
- Imaging Sciences InternationalMay 14, 2014
K133620 · CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM
- Palodex Group OYMar 26, 2014
K133544 · OP300
- TrophyMar 14, 2014
K133406 · CS 8100 3D
- Ray Co., Ltd.Nov 1, 2013
K131695 · RAYSCAN A-EXPERT 3D
- Lk Consulting GroupJul 18, 2013
K123332 · NAOMI-CT
- Qr S.R.L.Jul 3, 2013
K130442 · NEWTOM VGI AND NEWTOM 5G
- OwandyJun 14, 2013
K130443 · I-MAX TOUCH 3D
- VATECH Co., Ltd.May 31, 2013
K130432 · PHT-6500, PHT-60CFO
- Palodex Group OYMay 29, 2013
K130297 · SCANORA 3DX
- Cefla S.C.May 10, 2013
K123381 · HYPERION X9
- The Yoshida Dental Mfg. Co., Ltd.Apr 18, 2013
K122199 · PREXION3D ECLIPSE
- Sirona Dental Systems GmbHMar 15, 2013
K123070 · GALILEOS FAMILY
- Ray Co., Ltd.Mar 12, 2013
K122981 · RAYSCAN A-EXPERT 3D
- The Yoshida Dental Mfg. Co., Ltd.Dec 21, 2012
K120948 · PREXION 3D
- Palodex Group OYDec 10, 2012
K122018 · OP300
- MtechgroupNov 20, 2012
K122606 · PHT-6500; PHT-60CFO; PAX-I3D
- VATECH Co., Ltd.Aug 28, 2012
K121400 · PAX-UNI3D, PHT-7500
- Icrco, Inc.Jul 26, 2012
K120753 · CLARISCT
- VATECH Co., Ltd.Jun 8, 2012
K121412 · PAX-FLEX3D, PHT-7000
- VATECH Co., Ltd.May 24, 2012
K121236 · PAX-DUO3D PLUS, PCT-5000
- TrophyAug 18, 2011
K103659 · CS 9300, CS 9300C
- Takara Belmont Corp.Jul 19, 2011
K101181 · BEL-CAT
- Soredex Palodex Group OYJun 30, 2011
K110839 · SCANORA 3D
- Qr S.R.L.Apr 6, 2011
K110260 · NEWTOM 5G / NEWTOM 5G VERSION FP
- VATECH Co., Ltd.Mar 25, 2011
K102196 · COMPUTED TOMOGRAPHY X-RAY SYSTEM
- Sirona Dental Systems GmbHMar 22, 2011
K103711 · ORTHOPHOS XG 3D / CEPH
- VATECH Co., Ltd.Jan 8, 2010
K090467 · DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
- Suni Medical Imaging, Inc.Jun 2, 2009
K083917 · X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
- E-Woo TechnologyApr 30, 2009
K090171 · COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D
- E-Woo TechnologyOct 31, 2008
K082410 · MASTER3DS
- VATECH Co., Ltd.Oct 10, 2008
K082350 · PAX-500
- The Yoshida Dental Mfg. Co., Ltd.Feb 8, 2007
K063622 · FINECUBE DENTAL CT
- Instrumentarium Dental, Inc.Jan 31, 2007
K063773 · VOLUMETRIC TOMOGRAPHY
- Aperio Services, LLCMay 14, 2004
K041137 · NEWTOM 3G QR-DVT 9000
- Aperio Services, LLCMar 8, 2001
K003787 · NEWTOM QR-DVT 9000