X-ray, Tomography, Computed, Dental

Product Code: OAS

Radiology Dental Diagnostic X-Ray Equipment

Definition: Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31]

Code of Federal Regulations: 892.1750


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as OAS

5403X-ray, Tomography, Computed, DentalComputed Tomography X-ray System.

Total Product Life Cycle (TPLC) Devices

5403X-ray, Tomography, Computed, DentalComputed Tomography X-ray System.

FDA Consensus Standards

X-Ray, Tomography, Computed, Dental [37176]21 CFR §892.1750 🔎

Pre-market Notifications for OAS

K210329Green X 18(Model : PHT-75CHS)Vatech Co., Ltd
K201667Midmark Extraoral Imaging System (EOIS)Midmark Corporation
K2013783D Accuitomo 150NJ. Morita USA, INC.
K201140AxeosDentsply Sirona
K200688Hyperion X5, NewTom GO, X-RADiUS COMPACTCEFLA S.C.
K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co.,Ltd
K200271Rainbow CTDentium Co., Ltd (ICT Branch)
K200270Rainbow MCTDentium Co., Ltd (ICT Branch)
K193329PreXion3D Explorer EXPreXion Corporation
K193139ProVecta 3D Prime CephDurr Dental SE
K192737RCT800RAY CO., Ltd
K191616Orthophos SDentsply Sirona
K190856SeeFactorCT3Epica International Inc.
K190812RAYSCAN A-Expert3DRAY Co., Ltd
K190496Hyperion X9 Pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCEFLA S.C.

Global Unique Device Identification Database

06430035872879X-Ray, Tomography, Computed, Dental
06430035872862X-Ray, Tomography, Computed, Dental
06430035872770X-Ray, Tomography, Computed, Dental
06430035872763X-Ray, Tomography, Computed, Dental
06430035872756X-Ray, Tomography, Computed, Dental
06430035872749X-Ray, Tomography, Computed, Dental
06430035872732X-Ray, Tomography, Computed, Dental
06430035872725X-Ray, Tomography, Computed, Dental
06430035872688X-Ray, Tomography, Computed, Dental
06430035872282X-Ray, Tomography, Computed, Dental
06430035872275X-Ray, Tomography, Computed, Dental
06430035872268X-Ray, Tomography, Computed, Dental
06430035872251X-Ray, Tomography, Computed, Dental
06430035872244X-Ray, Tomography, Computed, Dental
06430035872213X-Ray, Tomography, Computed, Dental

Maude Adverse Events

RAYSCAN LEDRAY CO., LTD2019-02-26
PREXION 3D, TERARECON, YOSHIDA DENTALTERARECON, YOSHIDA DENTAL2008-07-30

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