Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)— 510(k) K260093
Substantially EquivalentVATECH Co., Ltd.
FDA 510(k) clearance K260093 for Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS), Substantially Equivalent on 2026-03-31. Applicant: VATECH Co., Ltd.. Device class: 2.
Summary
This VATECH record covers two names, Green X 12 VE and Green X VE, both carrying the designation PHT-70CHS. They're filed under OAS, dental computed tomography x-ray systems.
Class II, 21 CFR 892.1750. It was a Special 510(k), and Radiology is both the classification panel and the review panel.
VATECH filed from Hwaseong-Si, South Korea. The decision came 77 calendar days after FDA received it (January 13 to March 31, 2026).
Clearance details
- Applicant
- VATECH Co., Ltd.
- Product code
- Product code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hwaseong-Si, KR
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