Home / 510(k) Clearances / K240040

510(k) K240040

VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) by VATECH Co., Ltd. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2024
Date Received
January 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

Other clearances by VATECH Co., Ltd.

  • K243088 — Green X 12 SE (PHT-40CHS) (February 21, 2025)
  • K243081 — Green X 21 (PHT-90CHO) (February 14, 2025)
  • 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 MUH

  • K251793 — SOTA Cloud Smart Sensor (1.5) (March 3, 2026)
  • K252570 — EzSensor HD, EzSensor UHD (November 10, 2025)
  • K250687 — Cocoon Solo (DX-7020s) (October 24, 2025)
  • K251206 — Digital X-Ray DentiMax Pro Imaging System (September 24, 2025)
  • K242778 — X Sensor (Model: IOS-A15IF, HDI-15DGF) (October 11, 2024)
  • K241649 — DUO1 and DUO2 (July 5, 2024)
  • K232325 — RAYSCAN a-Expert (April 18, 2024)
  • K231660 — Digital image scanner of dental (December 20, 2023)
  • K233053 — DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 (November 21, 2023)
  • K232552 — TuxDeluxe (Size 1 6100B, Size 2 6101B) (October 20, 2023)