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 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K132983 | TON-95LH, PAX-I3D ORTHO | VATECH Co., Ltd. | 2014-08-07 | Traditional | PDF ↗ |
| K133620 | CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM | Imaging Sciences International | 2014-05-14 | Traditional | PDF ↗ |
| K133544 | OP300 | Palodex Group OY | 2014-03-26 | Special | PDF ↗ |
| K133406 | CS 8100 3D | Trophy | 2014-03-14 | Traditional | PDF ↗ |
| K131695 | RAYSCAN A-EXPERT 3D | Ray Co., Ltd. | 2013-11-01 | Special | PDF ↗ |
| K123332 | NAOMI-CT | Lk Consulting Group | 2013-07-18 | Traditional | PDF ↗ |
| K130442 | NEWTOM VGI AND NEWTOM 5G | Qr S.R.L. | 2013-07-03 | Traditional | PDF ↗ |
| K130443 | I-MAX TOUCH 3D | Owandy | 2013-06-14 | Abbreviated | PDF ↗ |
| K130432 | PHT-6500, PHT-60CFO | VATECH Co., Ltd. | 2013-05-31 | Special | PDF ↗ |
| K130297 | SCANORA 3DX | Palodex Group OY | 2013-05-29 | Special | PDF ↗ |
| K123381 | HYPERION X9 | Cefla S.C. | 2013-05-10 | Traditional | PDF ↗ |
| K122199 | PREXION3D ECLIPSE | The Yoshida Dental Mfg. Co., Ltd. | 2013-04-18 | Traditional | PDF ↗ |
| K123070 | GALILEOS FAMILY | Sirona Dental Systems GmbH | 2013-03-15 | Traditional | PDF ↗ |
| K122981 | RAYSCAN A-EXPERT 3D | Ray Co., Ltd. | 2013-03-12 | Traditional | PDF ↗ |
| K120948 | PREXION 3D | The Yoshida Dental Mfg. Co., Ltd. | 2012-12-21 | Traditional | PDF ↗ |
| K122018 | OP300 | Palodex Group OY | 2012-12-10 | Special | PDF ↗ |
| K122606 | PHT-6500; PHT-60CFO; PAX-I3D | Mtechgroup | 2012-11-20 | Special | PDF ↗ |
| K121400 | PAX-UNI3D, PHT-7500 | VATECH Co., Ltd. | 2012-08-28 | Special | PDF ↗ |
| K120753 | CLARISCT | Icrco, Inc. | 2012-07-26 | Traditional | PDF ↗ |
| K121412 | PAX-FLEX3D, PHT-7000 | VATECH Co., Ltd. | 2012-06-08 | Special | PDF ↗ |
| K121236 | PAX-DUO3D PLUS, PCT-5000 | VATECH Co., Ltd. | 2012-05-24 | Special | PDF ↗ |
| K103659 | CS 9300, CS 9300C | Trophy | 2011-08-18 | Traditional | PDF ↗ |
| K101181 | BEL-CAT | Takara Belmont Corp. | 2011-07-19 | Traditional | PDF ↗ |
| K110839 | SCANORA 3D | Soredex Palodex Group OY | 2011-06-30 | Traditional | PDF ↗ |
| K110260 | NEWTOM 5G / NEWTOM 5G VERSION FP | Qr S.R.L. | 2011-04-06 | Special | PDF ↗ |
| K102196 | COMPUTED TOMOGRAPHY X-RAY SYSTEM | VATECH Co., Ltd. | 2011-03-25 | Traditional | PDF ↗ |
| K103711 | ORTHOPHOS XG 3D / CEPH | Sirona Dental Systems GmbH | 2011-03-22 | Traditional | PDF ↗ |
| K090467 | DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D | VATECH Co., Ltd. | 2010-01-08 | Traditional | PDF ↗ |
| K083917 | X-RAY, TOMOGRAPHY, COMPUTED, DENTAL | Suni Medical Imaging, Inc. | 2009-06-02 | Traditional | PDF ↗ |
| K090171 | COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D | E-Woo Technology | 2009-04-30 | Traditional | PDF ↗ |
| K082410 | MASTER3DS | E-Woo Technology | 2008-10-31 | Traditional | PDF ↗ |
| K082350 | PAX-500 | VATECH Co., Ltd. | 2008-10-10 | Traditional | PDF ↗ |
| K063622 | FINECUBE DENTAL CT | The Yoshida Dental Mfg. Co., Ltd. | 2007-02-08 | Traditional | PDF ↗ |
| K063773 | VOLUMETRIC TOMOGRAPHY | Instrumentarium Dental, Inc. | 2007-01-31 | Traditional | PDF ↗ |
| K041137 | NEWTOM 3G QR-DVT 9000 | Aperio Services, LLC | 2004-05-14 | Special | PDF ↗ |
| K003787 | NEWTOM QR-DVT 9000 | Aperio Services, LLC | 2001-03-08 | Traditional | PDF ↗ |
Product code OAS · Class II · Radiology. Data: openFDA.