Dental Computed Tomography X-Ray System
FDA 510(k) K102124 · VATECH Co., Ltd.
510(k) numberK102124
Submission
- Device name
- Dental Computed Tomography X-Ray System
- Applicant
- VATECH Co., Ltd.
Secaucus, NJ, US - Received
- July 29, 2010
- Decision date
- October 22, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K251793 | SOTA Cloud Smart Sensor (1.5)MUH · Traditional | Sota Cloud Corp. | 03/03/2026SE |
| K252570 | EzSensor HD, EzSensor UHDMUH · Special | Qpix Solutions, Inc. | 11/10/2025SE |
| K250687 | Cocoon Solo (DX-7020s)MUH · Traditional | Dexcowin Global, Inc. | 10/24/2025SE |
| K251206 | Digital X-Ray DentiMax Pro Imaging SystemMUH · Traditional | Dentimax, Inc. | 09/24/2025SE |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan…MUH · Traditional | VATECH Co., Ltd. | 10/25/2024SE |
| K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF)MUH · Special | Qpix Solutions, Inc. | 10/11/2024SE |
| K241649 | DUO1 and DUO2MUH · Traditional | Zinnovi, Inc. | 07/05/2024SE |
| K232325 | RAYSCAN a-ExpertMUH · Traditional | Ray Co., Ltd. | 04/18/2024SE |
| K231660 | Digital image scanner of dentalMUH · Traditional | Jiangsu Dynamic Medical Technology Co., Ltd. | 12/20/2023SE |
| K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2…MUH · Traditional | Dental Imaging Technologies Corporation | 11/21/2023SE |
More from Dental Imaging Technologies Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)OAS · Special | 03/31/2026SE |
| K243088 | Green X 12 SE (PHT-40CHS)OAS · Special | 02/21/2025SE |
| K243081 | Green X 21 (PHT-90CHO)OAS · Traditional | 02/14/2025SE |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan…MUH · Traditional | 10/25/2024SE |
| K231796 | Grreen X 12 (Model: PHT-75CHS)OAS · Special | 07/19/2023SE |
| K223058 | EzRay Air 2 Wall (Model: VEX-S350W)EHD · Special | 10/26/2022SE |
| K213462 | EzRay M18 (Model: VMX-P400)IZL · Traditional | 02/11/2022SE |
| K210329 | Green X 18(Model : PHT-75CHS)OAS · Special | 02/18/2021SE |
| K203667 | EzRay M (Model: VMX-P300)IZL · Traditional | 02/02/2021SE |
| K203797 | vatech A9 (Model : PHT-30CSS)OAS · Special | 01/25/2021SE |
Questions and answers
When was Dental Computed Tomography X-Ray System cleared by the FDA?
Dental Computed Tomography X-Ray System (K102124) received a 510(k) decision of Substantially Equivalent on October 22, 2010, 85 days after the submission was received.
What is the product code of K102124?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.