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510(k) K232287

RAYSCAN a-Expert3D by Ray Co., Ltd. — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2023
Date Received
August 1, 2023
Clearance Type
Special
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 Ray Co., Ltd.

  • K251798 — RCT700 (November 25, 2025)
  • K251109 — SMARTDent (May 21, 2025)
  • K243903 — RCT600 (March 12, 2025)
  • K233625 — RAYDENT SW (May 16, 2024)
  • K232325 — RAYSCAN a-Expert (April 18, 2024)
  • K230753 — RCT800 (April 11, 2023)
  • K213226 — RCT700 (November 29, 2021)
  • K211105 — Ear-Friendly Mask (May 17, 2021)
  • K192737 — RCT800 (October 22, 2019)
  • K190812 — RAYSCAN a-Expert3D (April 24, 2019)

Other clearances for product code OAS

  • K252353 — myray ProXIma X6 (March 10, 2026)
  • K253959 — Primevision 3D (February 5, 2026)
  • K251798 — RCT700 (November 25, 2025)
  • 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)
  • K243081 — Green X 21 (PHT-90CHO) (February 14, 2025)