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510(k) K181452

RCT800 by Ray Co., Ltd. — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2018
Date Received
June 1, 2018
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 Ray Co., Ltd.

  • K260462 — RCT800 (April 9, 2026)
  • 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)
  • K232287 — RAYSCAN a-Expert3D (August 31, 2023)
  • K230753 — RCT800 (April 11, 2023)
  • K213226 — RCT700 (November 29, 2021)
  • K211105 — Ear-Friendly Mask (May 17, 2021)

Other clearances for product code OAS

  • K250839 — Dental X-ray System (June 11, 2026)
  • K260662 — Dental Cone Beam Computed Tomography System (June 4, 2026)
  • K253935 — medXion NEXUS (May 15, 2026)
  • K260462 — RCT800 (April 9, 2026)
  • K260093 — Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (March 31, 2026)
  • 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)