PAX-FLEX3D, PHT-7000— 510(k) K121412

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K121412 for PAX-FLEX3D, PHT-7000, Substantially Equivalent on 2012-06-08. Applicant: VATECH Co., Ltd.. Device class: 2.

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2012-05-11
Decision date: 2012-06-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OAS

K261748 — Dental Cone-beam Computed Tomography (mDX-15P Series)2026-07-23
K250839 — Dental X-ray System2026-06-11
K260662 — Dental Cone Beam Computed Tomography System2026-06-04
K253935 — medXion NEXUS2026-05-15
K260462 — RCT8002026-04-09

More clearances from VATECH Co., Ltd.

K260093 — Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)2026-03-31
K243088 — Green X 12 SE (PHT-40CHS)2025-02-21
K243081 — Green X 21 (PHT-90CHO)2025-02-14
K240040 — VistaPano S Ceph 2.0 (VistaPano S Ceph) +3 more2024-10-25
K231796 — Grreen X 12 (Model: PHT-75CHS)2023-07-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.