VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)
FDA 510(k) K240040 · VATECH Co., Ltd.
510(k) numberK240040
Submission
- Device name
- VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)
- Applicant
- VATECH Co., Ltd.
Hwaseong-Si, KR - Received
- January 5, 2024
- Decision date
- October 25, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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Questions and answers
When was VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) cleared by the FDA?
VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) (K240040) received a 510(k) decision of Substantially Equivalent on October 25, 2024, 294 days after the submission was received.
What is the product code of K240040?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.