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

K221525PreXion3D Explorer PROPreXion Corporation
K220392PAPAYA 3D & PAPAYA 3D PlusGENORAY Co., Ltd.
K214084Hyperion X9 Pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCEFLA S.C.
K213278Planmed VerityPlanmed Oy
K213226RCT700RAY Co., Ltd
K212303T2Osstem Implant Co., Ltd.
K212254DENTRIa Series (DENTRIa, DENTRI-Ca, DENTRI-Sa)HDX Will Corp.
K211159Eco-x Series (eco-x, Eco-x-s)HDX WILL Corp.
K210329Green X 18(Model : PHT-75CHS)Vatech Co., Ltd
K203797Vatech A9 (Model : PHT-30CSS)Vatech Co., Ltd
K201667Midmark Extraoral Imaging System (EOIS)Midmark Corporation
K201627Dental Computed Tomography X-Ray System, Green XVatech Co., Ltd
K201382X-MIND Prime 3D (under Trademark Acteon), I-MAX 3D (under Trademark Owandy Radiology)De Gotzen S.r.l.
K2013783D Accuitomo 150NJ. Morita USA, INC.
K201140AxeosDentsply Sirona

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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