FDA Product Code
FDA Product Code OAS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1750
510(k) Clearances — 136 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K263033 | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) | Fussen Technology Co., Ltd. | 2026-09-30 | Special | PDF ↗ |
| K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series) | Hefei Meyer Optoelectronic Technology, Inc. | 2026-07-23 | Traditional | PDF ↗ |
| K250839 | Dental X-ray System | Changzhou Boen Zhongding Medical Technology Co., Ltd. | 2026-06-11 | Traditional | PDF ↗ |
| K260662 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | 2026-06-04 | Special | PDF ↗ |
| K253935 | medXion NEXUS | medXion Technologies, Inc. | 2026-05-15 | Traditional | PDF ↗ |
| K260462 | RCT800 | Ray Co., Ltd. | 2026-04-09 | Special | PDF ↗ |
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | VATECH Co., Ltd. | 2026-03-31 | Special | PDF ↗ |
| K252353 | myray ProXIma X6 | Cefla S.C. | 2026-03-10 | Traditional | PDF ↗ |
| K253959 | Primevision 3D | Dentsply Sirona | 2026-02-05 | Traditional | PDF ↗ |
| K251798 | RCT700 | Ray Co., Ltd. | 2025-11-25 | Traditional | PDF ↗ |
| K251842 | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd. | 2025-11-13 | Traditional | PDF ↗ |
| K250060 | GT300; GT300-C | Genoray Co., Ltd. | 2025-10-08 | Traditional | PDF ↗ |
| K251642 | Dental CBCT X-ray System | Yian Medical Technology (Haining) Co., Ltd. | 2025-06-27 | Special | PDF ↗ |
| K243337 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | 2025-04-17 | Traditional | PDF ↗ |
| K243903 | RCT600 | Ray Co., Ltd. | 2025-03-12 | Traditional | PDF ↗ |
| K243088 | Green X 12 SE (PHT-40CHS) | VATECH Co., Ltd. | 2025-02-21 | Special | PDF ↗ |
| K243081 | Green X 21 (PHT-90CHO) | VATECH Co., Ltd. | 2025-02-14 | Traditional | PDF ↗ |
| K242805 | Dental Cone-beam Computed Tomography (FinScan F350) | Changzhou Finno Medical Technology Co., Ltd. | 2025-01-09 | Traditional | PDF ↗ |
| K241249 | Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) | Palodex Group OY | 2024-09-12 | Traditional | PDF ↗ |
| K233806 | T2 Plus | Osstem Implant Co., Ltd. | 2024-09-06 | Traditional | PDF ↗ |
| K240855 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | 2024-04-25 | Special | PDF ↗ |
| K232710 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | 2024-01-09 | Traditional | PDF ↗ |
| K230985 | Planmeca Viso | Planmeca Oy | 2023-12-28 | Traditional | PDF ↗ |
| K231181 | bright CT | Dentium Co., Ltd (Ict Branch) | 2023-12-14 | Special | PDF ↗ |
| K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | Durr Dental SE | 2023-09-14 | Special | PDF ↗ |
| K232166 | PreXion3D Expedition | Prexion Corporation | 2023-09-08 | Traditional | PDF ↗ |
| K232287 | RAYSCAN a-Expert3D | Ray Co., Ltd. | 2023-08-31 | Special | PDF ↗ |
| K231796 | Grreen X 12 (Model: PHT-75CHS) | VATECH Co., Ltd. | 2023-07-19 | Special | PDF ↗ |
| K222666 | X-View 3D Pan/X-View 2D Pan | Trident S.R.L | 2023-07-10 | Traditional | PDF ↗ |
| K230505 | Orthopantomograph OP 3D LX | Palodex Group OY | 2023-06-09 | Traditional | PDF ↗ |
| K230753 | RCT800 | Ray Co., Ltd. | 2023-04-11 | Special | PDF ↗ |
| K223816 | Dental CT Scanner AXR | Alliage S/A Industrias Medico Odontológica | 2023-04-07 | Abbreviated | PDF ↗ |
| K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | 2023-01-17 | Special | PDF ↗ |
| K222150 | PreXion3D Expedition | Prexion Corporation | 2023-01-12 | Traditional | PDF ↗ |
| K222219 | R2 Studio Q/RCT820 | Megagen Implant Co., Ltd. | 2022-12-06 | Traditional | PDF ↗ |
| K221525 | PreXion3D Explorer PRO | Prexion Corporation | 2022-07-22 | Traditional | PDF ↗ |
| K220392 | PAPAYA 3D & PAPAYA 3D Plus | Genoray Co., Ltd. | 2022-05-19 | Traditional | PDF ↗ |
| K213278 | Planmed Verity | Planmed OY | 2022-04-28 | Traditional | PDF ↗ |
| K213579 | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | Fona S.R.L | 2022-03-02 | Traditional | PDF ↗ |
| K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | 2022-01-20 | Special | PDF ↗ |
| K211159 | eco-x Series (eco-x, eco-x-s) | Hdx Will Corp. | 2021-12-30 | Traditional | PDF ↗ |
| K213226 | RCT700 | Ray Co., Ltd. | 2021-11-29 | Traditional | PDF ↗ |
| K212254 | DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) | Hdx Will Corp. | 2021-10-19 | Traditional | PDF ↗ |
| K212303 | T2 | Osstem Implant Co., Ltd. | 2021-09-21 | Traditional | PDF ↗ |
| K210820 | EAGLE EDGE AXR90 and AXR120 | Alliage S/A Industrias Medico Odontológica | 2021-08-10 | Abbreviated | PDF ↗ |
| K200271 | rainbow CT | Dentium Co., Ltd (Ict Branch) | 2021-04-16 | Traditional | PDF ↗ |
| K200270 | rainbow MCT | Dentium Co., Ltd (Ict Branch) | 2021-04-16 | Traditional | PDF ↗ |
| K203784 | PreXion3D Explorer PRO | Prexion Corporation | 2021-02-23 | Traditional | PDF ↗ |
| K201378 | 3D Accuitomo 150N | J. Morita USA, Inc. | 2021-02-18 | Traditional | PDF ↗ |
| K210329 | Green X 18(Model : PHT-75CHS) | VATECH Co., Ltd. | 2021-02-18 | Special | PDF ↗ |
| K203797 | vatech A9 (Model : PHT-30CSS) | VATECH Co., Ltd. | 2021-01-25 | Special | PDF ↗ |
| K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) | De Gotzen S.R.L. | 2020-11-18 | Abbreviated | PDF ↗ |
| K201627 | Dental Computed Tomography X-Ray System, Green X | VATECH Co., Ltd. | 2020-10-27 | Traditional | PDF ↗ |
| K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | Genoray Co., Ltd. | 2020-09-16 | Traditional | PDF ↗ |
| K201667 | Midmark Extraoral Imaging System (EOIS) | Midmark Corporation | 2020-08-06 | Traditional | PDF ↗ |
| K201140 | Axeos | Dentsply Sirona | 2020-06-22 | Traditional | PDF ↗ |
| K193329 | PreXion3D Explorer EX | Prexion Corporation | 2020-04-09 | Traditional | PDF ↗ |
| K200688 | hyperion X5, NewTom GO, X-RADiUS COMPACT | Cefla S.C. | 2020-04-09 | Traditional | PDF ↗ |
| K200183 | CS 9600 | Trophy | 2020-03-13 | Traditional | PDF ↗ |
| K193139 | ProVecta 3D Prime Ceph | Durr Dental SE | 2020-03-05 | Traditional | PDF ↗ |
| K192737 | RCT800 | Ray Co., Ltd. | 2019-10-22 | Traditional | PDF ↗ |
| K190856 | SeeFactorCT3 | Epica International, Inc. | 2019-09-20 | Traditional | PDF ↗ |
| K183475 | T1-CS, T1-C | Osstem Implant Co., Ltd. | 2019-08-30 | Traditional | PDF ↗ |
| K191616 | Orthophos S | Dentsply Sirona | 2019-07-16 | Traditional | PDF ↗ |
| K190812 | RAYSCAN a-Expert3D | Ray Co., Ltd. | 2019-04-24 | Special | PDF ↗ |
| K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | 2019-04-24 | Traditional | PDF ↗ |
| K190320 | PreXion3D Explorer | Prexion Corporation | 2019-04-15 | Traditional | PDF ↗ |
| K182805 | RCT800 | Ray Co., Ltd. | 2018-12-14 | Special | PDF ↗ |
| K180918 | Planmed Verity | Planmed OY | 2018-11-30 | Traditional | PDF ↗ |
| K180601 | Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) | Villa Sistemi Medicali S.P.A. | 2018-11-02 | Abbreviated | PDF ↗ |
| K182614 | RCT700 | Ray Co., Ltd. | 2018-10-16 | Special | PDF ↗ |
| K181576 | Planmeca Viso | Planmeca Oy | 2018-09-13 | Traditional | PDF ↗ |
| K181983 | PreXion 3D Excelsior | Prexion Corporation | 2018-08-17 | Special | PDF ↗ |
| K181432 | ProVectra 3D Prime with VistaSoft | Durr Dental SE | 2018-08-02 | Traditional | PDF ↗ |
| K181452 | RCT800 | Ray Co., Ltd. | 2018-07-27 | Traditional | PDF ↗ |
| K180947 | Orthopantomograph OP 3D | Palodex Group OY | 2018-06-07 | Traditional | PDF ↗ |
| K181136 | CS 9600 | Trophy | 2018-05-24 | Traditional | PDF ↗ |
| K173878 | PreXion3D Excelsior | Prexion Corporation | 2018-01-19 | Special | PDF ↗ |
| K171012 | Veraview X800 | J. Morita USA, Inc. | 2017-12-19 | Traditional | PDF ↗ |
| K163423 | Orthopantomograph OP300 | Palodex Group OY | 2017-08-31 | Traditional | PDF ↗ |
| K170066 | Green16/Green18 (Model: PHT-65LHS) | VATECH Co., Ltd. | 2017-06-16 | Traditional | PDF ↗ |
| K170813 | ORTHOPANTOMOGRAPH OP 3D | Palodex Group OY | 2017-04-07 | Traditional | PDF ↗ |
| K161900 | HYPERION X5 | Cefla S.C. | 2016-12-09 | Traditional | PDF ↗ |
| K160166 | X-MIND trium | De Gotzen S.R.L. | 2016-11-15 | Abbreviated | PDF ↗ |
| K162085 | i-CAT FLX V series / KaVo 3D eXam+ V series | Imaging Sciences International | 2016-11-10 | Traditional | PDF ↗ |
| K160882 | PaX-i3D Green Premium (Model: PCT-90LH) | VATECH Co., Ltd. | 2016-10-28 | Traditional | PDF ↗ |
| K162660 | Green Smart (Model: PHT-35LHS) | VATECH Co., Ltd. | 2016-10-20 | Special | PDF ↗ |
| K161881 | PreXion3D Excelsior | Prexion Corporation | 2016-10-03 | Traditional | PDF ↗ |
| K160140 | DENTRIa series | Hdx Will Corp. | 2016-09-30 | Traditional | PDF ↗ |
| K160525 | RCT700 | Ray Co., Ltd. | 2016-06-20 | Traditional | PDF ↗ |
| K151137 | X-VIEW, IMAGEN | Edlen Imaging, LLC | 2016-06-07 | Abbreviated | PDF ↗ |
| K160506 | Planmeca ProMax 3D Max, Planmeca Maximity | Planmeca Oy | 2016-05-20 | Traditional | PDF ↗ |
| K151612 | NewTom VGi evo | Qr S.R.L. | 2016-03-31 | Traditional | PDF ↗ |
| K152489 | ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray | Panoramic Corp. | 2016-02-04 | Traditional | PDF ↗ |
| K150354 | PAPAYA 3D Plus | Genoray Co., Ltd. | 2015-12-10 | Traditional | PDF ↗ |
| K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | VATECH Co., Ltd. | 2015-10-23 | Traditional | PDF ↗ |
| K143435 | Planmed Verity | Planmed OY | 2015-05-14 | Traditional | PDF ↗ |
| K150217 | ORTHOPHOS SL | Sirona Dental Systems GmbH | 2015-05-08 | Traditional | PDF ↗ |
| K142247 | RAYSCAN A-EXPERT 3D | Ray Co., Ltd. | 2015-04-17 | Traditional | PDF ↗ |
| K133797 | QMASTER-H/REVO | Telesystems Co., Ltd. | 2014-09-04 | Traditional | PDF ↗ |
Product code OAS · Class II · Radiology. Data: openFDA.