← Back to catalogue
Pch-2500 Digital Extraoral Source X-Ray System, Pax-I Digital Extraoral Source …
FDA 510(k)Class II (US FDA 510(k))
510(k) K130585
Identifiers
- 510(k) Number
- K130585 FDA 510(k)
- FDA Product Code
- MUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1800 FDA 510(k)
- Regulation Number
- 872.1800 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Pch-2500 Digital Extraoral Source X-Ray System, Pax-I Digital Extraoral Source … 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 | K130585 | 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) K130585 24 fields · synced Jun 18, 2026