Home / 510(k) Clearances / K213462

510(k) K213462

EzRay M18 (Model: VMX-P400) by VATECH Co., Ltd. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2022
Date Received
October 27, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
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)
  • K240040 — VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta (October 25, 2024)
  • K231796 — Grreen X 12 (Model: PHT-75CHS) (July 19, 2023)
  • K223058 — EzRay Air 2 Wall (Model: VEX-S350W) (October 26, 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 IZL

  • K253185 — Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System (March 11, 2026)
  • K253244 — AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) (February 23, 2026)
  • K250976 — Airbile-100 (December 19, 2025)
  • K251710 — Mobile X-ray unit (!M1) (October 24, 2025)
  • K243864 — BONX805 (September 12, 2025)
  • K251443 — PROMO (August 22, 2025)
  • K251223 — HnX-P1, HnX-PB (August 4, 2025)
  • K250597 — REMEX Xcam6 (July 31, 2025)
  • K243473 — PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS (July 29, 2025)
  • K250750 — INNOVISION-P5 (July 18, 2025)