Radiotecnología Industrial, S.A. de C.V.

Address:Calle Puebla Sur Manz. 4 Lote 5,Ixtapaluca Mexico,MX

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Unit, X-Ray, Extraoral With Timer (EHD) (2)

Premarket Exempt

Clear

BI Image-X - D881RXEMWEXP0 Catalog Number :

Device Description : The BI IMAGE-X EVOLUTION® device is an extraoral x-ray generator that provides t The BI IMAGE-X EVOLUTION® device is an extraoral x-ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.The BI IMAGE-X EVOLUTION® is an extraoral x-ray generator system designed to be used in combination with an intraoral image receptor for radiographic examinations (which assist in diagnosis of diseases of the teeth, jaw, and oral structure) by dental professionals.

Device Class : 2

Duns Number: 812635448

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

BI Image-X - D881RXEPWEXP0 Catalog Number :