Home / 510(k) Clearances / K190496

510(k) K190496

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS by Cefla S.C. — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2019
Date Received
February 28, 2019
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.

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  • K220664 — NewTom 7G (May 6, 2022)
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  • 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)