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510(k) K240855

Dental Cone-beam Computed Tomography by Yian Medical Technology (Haining) Co., Ltd. — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2024
Date Received
March 28, 2024
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 Yian Medical Technology (Haining) Co., Ltd.

  • K251642 — Dental CBCT X-ray System (June 27, 2025)
  • K232710 — Dental Cone-beam Computed Tomography (January 9, 2024)
  • K220700 — Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine (May 4, 2022)

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)