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BI Image-X

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
BI Image-X FDA UDI
Generic Name
Stationary extraoral dental x-ray system, analogue FDA UDI
Device Name
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. FDA UDI
Model / Reference
Evolution FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
D881RXEMWEXP0 FDA UDI
510(k) Number
K160458 FDA UDI
FDA Product Code
EHD FDA UDI
GMDN Term
Stationary extraoral dental x-ray system, analogue FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Angle — 180 degree FDA UDI
Length — 2.2 Meter FDA UDI
Height — 2 Meter FDA UDI

Category: Stationary extraoral dental x-ray system, analogue

BI Image-X by Radiotecnología Industrial, S.A. de C.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary extraoral dental x-ray system, analogue.

Cleared under the same submission

K160458 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

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

Sources (1)

  • FDA UDI 224e081f-2734-485e-8680-4b98743ef46a 37 fields · synced Jun 8, 2026