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510(k) K243081

Green X 21 (PHT-90CHO) by VATECH Co., Ltd. — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2025
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
X-Ray, Tomography, Computed, Dental
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

Other clearances by VATECH Co., Ltd.

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  • K231796 — Grreen X 12 (Model: PHT-75CHS) (July 19, 2023)
  • K223058 — EzRay Air 2 Wall (Model: VEX-S350W) (October 26, 2022)
  • K213462 — EzRay M18 (Model: VMX-P400) (February 11, 2022)
  • K210329 — Green X 18(Model : PHT-75CHS) (February 18, 2021)
  • K203667 — EzRay M (Model: VMX-P300) (February 2, 2021)
  • K203797 — vatech A9 (Model : PHT-30CSS) (January 25, 2021)
  • K201627 — Dental Computed Tomography X-Ray System, Green X (October 27, 2020)
  • K200182 — EzRay Air Portable (Model: VEX-P300) (February 11, 2020)

Other clearances for product code OAS

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  • K251842 — Dental Computed Tomography X-ray System (November 13, 2025)
  • K250060 — GT300; GT300-C (October 8, 2025)
  • K251642 — Dental CBCT X-ray System (June 27, 2025)
  • K243337 — Dental Cone Beam Computed Tomography System (April 17, 2025)
  • K243903 — RCT600 (March 12, 2025)
  • K243088 — Green X 12 SE (PHT-40CHS) (February 21, 2025)
  • K242805 — Dental Cone-beam Computed Tomography (FinScan F350) (January 9, 2025)