← Back to catalogue
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart
FDA 510(k)Class II (US FDA 510(k))
510(k) K152106
Identifiers
- 510(k) Number
- K152106 FDA 510(k)
- FDA Product Code
- OAS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart by Vatech Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152106 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vatech Co., Ltd.
Sources (1)
- FDA 510(k) K152106 24 fields · synced Jun 19, 2026