FDA 510(k) Applications for Medical Device Product Code "OAS"
(X-Ray, Tomography, Computed, Dental)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K210820 | Alliage S/A Industrias Medico Odontol≤gica | EAGLE EDGE AXR90 and AXR120 | 08/10/2021 |
| K223816 | Alliage S/A Industrias Medico Odontol≤gica. | Dental CT Scanner AXR | 04/07/2023 |
| K041137 | APERIO SERVICES, LLC | NEWTOM 3G QR-DVT 9000 | 05/14/2004 |
| K003787 | APERIO SERVICES, LLC | NEWTOM QR-DVT 9000 | 03/08/2001 |
| K200688 | CEFLA S.C. | hyperion X5, NewTom GO, X-RADiUS COMPACT | 04/09/2020 |
| K123381 | CEFLA S.C. | HYPERION X9 | 05/10/2013 |
| K190496 | CEFLA S.C. | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | 04/24/2019 |
| K214084 | CEFLA S.C. | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | 01/20/2022 |
| K223794 | CEFLA S.C. | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | 01/17/2023 |
| K161900 | CEFLA SC | HYPERION X5 | 12/09/2016 |
| K201382 | de Gotzen S.r.l. | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) | 11/18/2020 |
| K160166 | DE GOTZEN S.R.L. | X-MIND trium | 11/15/2016 |
| K200271 | Dentium Co., Ltd (ICT Branch) | rainbow CT | 04/16/2021 |
| K200270 | Dentium Co., Ltd (ICT Branch) | rainbow MCT | 04/16/2021 |
| K201140 | Dentsply Sirona | Axeos | 06/22/2020 |
| K191616 | Dentsply Sirona | Orthophos S | 07/16/2019 |
| K232487 | Durr Dental SE | Provecta 3D Prime and Provecta 3D Prime Ceph | 09/14/2023 |
| K193139 | Durr Dental SE | ProVecta 3D Prime Ceph | 03/05/2020 |
| K181432 | Durr Dental SE | ProVectra 3D Prime with VistaSoft | 08/02/2018 |
| K090171 | E-WOO TECHNOLOGY | COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D | 04/30/2009 |
| K082410 | E-WOO TECHNOLOGY | MASTER3DS | 10/31/2008 |
| K151137 | EDLEN IMAGING LLC | X-VIEW, IMAGEN | 06/07/2016 |
| K190856 | Epica International Inc. | SeeFactorCT3 | 09/20/2019 |
| K213579 | FONA S.r.l | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | 03/02/2022 |
| K220392 | GENORAY Co., Ltd. | PAPAYA 3D & PAPAYA 3D Plus | 05/19/2022 |
| K150354 | GENORAY CO., LTD. | PAPAYA 3D Plus | 12/10/2015 |
| K200469 | Genoray Co.,Ltd | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | 09/16/2020 |
| K160140 | HDX WILL CORP. | DENTRIa series | 09/30/2016 |
| K212254 | HDX Will Corp. | DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) | 10/19/2021 |
| K211159 | HDX WILL Corp. | eco-x Series (eco-x, eco-x-s) | 12/30/2021 |
| K120753 | ICRCO INC. | CLARISCT | 07/26/2012 |
| K133620 | IMAGING SCIENCES INTERNATIONAL | CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM | 05/14/2014 |
| K162085 | IMAGING SCIENCES INTERNATIONAL | i-CAT FLX V series / KaVo 3D eXam+ V series | 11/10/2016 |
| K063773 | INSTRUMENTARIUM DENTAL INC. | VOLUMETRIC TOMOGRAPHY | 01/31/2007 |
| K201378 | J. Morita USA, INC. | 3D Accuitomo 150N | 02/18/2021 |
| K171012 | J.Morita USA, Inc. | Veraview X800 | 12/19/2017 |
| K123332 | LK CONSULTING GROUP | NAOMI-CT | 07/18/2013 |
| K222219 | MegaGen Implant CO., Ltd. | R2 Studio Q/RCT820 | 12/06/2022 |
| K201667 | Midmark Corporation | Midmark Extraoral Imaging System (EOIS) | 08/06/2020 |
| K122606 | MTECH GROUP | PHT-6500; PHT-60CFO; PAX-I3D | 11/20/2012 |
| K183475 | Osstem Implant Co., Ltd. | T1-CS, T1-C | 08/30/2019 |
| K212303 | Osstem Implant Co., Ltd. | T2 | 09/21/2021 |
| K130443 | OWANDY | I-MAX TOUCH 3D | 06/14/2013 |
| K122018 | PALODEX GROUP OY | OP300 | 12/10/2012 |
| K133544 | PALODEX GROUP OY | OP300 | 03/26/2014 |
| K170813 | PaloDEx Group Oy | ORTHOPANTOMOGRAPH OP 3D | 04/07/2017 |
| K180947 | PaloDEx Group Oy | Orthopantomograph OP 3D | 06/07/2018 |
| K163423 | PaloDEx Group Oy | Orthopantomograph OP300 | 08/31/2017 |
| K230505 | Palodex Group OY | OrthopantomographÖ OP 3D LX | 06/09/2023 |
| K130297 | PALODEX GROUP OY | SCANORA 3DX | 05/29/2013 |
| K152489 | PANORAMIC CORP. | ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray | 02/04/2016 |
| K160506 | PLANMECA OY | Planmeca ProMax 3D Max, Planmeca Maximity | 05/20/2016 |
| K181576 | Planmeca Oy | Planmeca Viso | 09/13/2018 |
| K143435 | PLANMED OY | Planmed Verity | 05/14/2015 |
| K180918 | Planmed Oy | Planmed Verity | 11/30/2018 |
| K213278 | Planmed Oy | Planmed Verity | 04/28/2022 |
| K181983 | PreXion Corporation | PreXion 3D Excelsior | 08/17/2018 |
| K173878 | PreXion Corporation | PreXion3D Excelsior | 01/19/2018 |
| K161881 | PreXion Corporation | PreXion3D Excelsior | 10/03/2016 |
| K222150 | PreXion Corporation | PreXion3D Expedition | 01/12/2023 |
| K232166 | PreXion Corporation | PreXion3D Expedition | 09/08/2023 |
| K190320 | PreXion Corporation | PreXion3D Explorer | 04/15/2019 |
| K193329 | PreXion Corporation | PreXion3D Explorer EX | 04/09/2020 |
| K203784 | PreXion Corporation | PreXion3D Explorer PRO | 02/23/2021 |
| K221525 | PreXion Corporation | PreXion3D Explorer PRO | 07/22/2022 |
| K110260 | QR S.R.L. | NEWTOM 5G / NEWTOM 5G VERSION FP | 04/06/2011 |
| K130442 | QR S.R.L. | NEWTOM VGI AND NEWTOM 5G | 07/03/2013 |
| K151612 | QR S.r.l. | NewTom VGi evo | 03/31/2016 |
| K142247 | RAY CO., LTD | RAYSCAN A-EXPERT 3D | 04/17/2015 |
| K131695 | RAY CO., LTD | RAYSCAN A-EXPERT 3D | 11/01/2013 |
| K122981 | RAY CO., LTD | RAYSCAN A-EXPERT 3D | 03/12/2013 |
| K190812 | RAY Co., Ltd | RAYSCAN a-Expert3D | 04/24/2019 |
| K213226 | RAY Co., Ltd | RCT700 | 11/29/2021 |
| K182805 | RAY Co., Ltd | RCT800 | 12/14/2018 |
| K192737 | RAY CO., Ltd | RCT800 | 10/22/2019 |
| K232287 | Ray Co., Ltd. | RAYSCAN a-Expert3D | 08/31/2023 |
| K230753 | Ray Co., Ltd. | RCT800 | 04/11/2023 |
| K181452 | Ray Co., Ltd. | RCT800 | 07/27/2018 |
| K182614 | RAY Co.,Ltd | RCT700 | 10/16/2018 |
| K160525 | RAY CO.,LTD | RCT700 | 06/20/2016 |
| K123070 | SIRONA DENTAL SYSTEMS GMBH | GALILEOS FAMILY | 03/15/2013 |
| K150217 | Sirona Dental Systems GMBH | ORTHOPHOS SL | 05/08/2015 |
| K103711 | SIRONA DENTAL SYSTEMS GMBH | ORTHOPHOS XG 3D / CEPH | 03/22/2011 |
| K110839 | SOREDEX PALODEX GROUP OY | SCANORA 3D | 06/30/2011 |
| K083917 | SUNI MEDICAL IMAGING, INC. | X-RAY, TOMOGRAPHY, COMPUTED, DENTAL | 06/02/2009 |
| K101181 | TAKARA BELMONT CORP. | BEL-CAT | 07/19/2011 |
| K133797 | TELESYSTEMS CO., LTD. | QMASTER-H/REVO | 09/04/2014 |
| K063622 | THE YOSHIDA DENTAL MFG. CO., LTD. | FINECUBE DENTAL CT | 02/08/2007 |
| K120948 | THE YOSHIDA DENTAL MFG. CO., LTD. | PREXION 3D | 12/21/2012 |
| K122199 | THE YOSHIDA DENTAL MFG. CO., LTD. | PREXION3D ECLIPSE | 04/18/2013 |
| K222666 | Trident s.r.l | X-View 3D Pan/X-View 2D Pan | 07/10/2023 |
| K133406 | TROPHY | CS 8100 3D | 03/14/2014 |
| K103659 | TROPHY | CS 9300, CS 9300C | 08/18/2011 |
| K181136 | Trophy | CS 9600 | 05/24/2018 |
| K200183 | Trophy | CS 9600 | 03/13/2020 |
| K201627 | Vatech Co., Ltd | Dental Computed Tomography X-Ray System, Green X | 10/27/2020 |
| K152106 | VATECH CO., LTD | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | 10/23/2015 |
| K162660 | VATECH CO., LTD | Green Smart (Model: PHT-35LHS) | 10/20/2016 |
| K210329 | Vatech Co., Ltd | Green X 18(Model : PHT-75CHS) | 02/18/2021 |
| K231796 | Vatech Co., Ltd | Grreen X 12 (Model: PHT-75CHS) | 07/19/2023 |
| K160882 | VATECH CO., LTD | PaX-i3D Green Premium (Model: PCT-90LH) | 10/28/2016 |
| K203797 | Vatech Co., Ltd | vatech A9 (Model : PHT-30CSS) | 01/25/2021 |
| K102196 | VATECH CO., LTD. | COMPUTED TOMOGRAPHY X-RAY SYSTEM | 03/25/2011 |
| K090467 | VATECH CO., LTD. | DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D | 01/08/2010 |
| K170066 | VATECH CO., LTD. | Green16/Green18 (Model: PHT-65LHS) | 06/16/2017 |
| K082350 | VATECH CO., LTD. | PAX-500 | 10/10/2008 |
| K121236 | VATECH CO., LTD. | PAX-DUO3D PLUS, PCT-5000 | 05/24/2012 |
| K121412 | VATECH CO., LTD. | PAX-FLEX3D, PHT-7000 | 06/08/2012 |
| K121400 | VATECH CO., LTD. | PAX-UNI3D, PHT-7500 | 08/28/2012 |
| K130432 | VATECH CO., LTD. | PHT-6500, PHT-60CFO | 05/31/2013 |
| K132983 | VATECH CO., LTD. | TON-95LH, PAX-I3D ORTHO | 08/07/2014 |
| K180601 | Villa Sistemi Medicali S.p.A. | Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) | 11/02/2018 |
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