BI Image-X

GUDID D881RXEMWEXP0

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.

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

Stationary extraoral dental x-ray system, analogue Stationary extraoral dental x-ray system, analogue

• Primary Device ID: D881RXEMWEXP0
• NIH Device Record Key: 224e081f-2734-485e-8680-4b98743ef46a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BI Image-X
• Version Model Number: Evolution
• Company DUNS: 812635448
• Company Name: Radiotecnología Industrial, S.A. de C.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1800-403-1890
• Email: dpmusaco@msn.com
• Phone: 1800-403-1890
• Email: dpmusaco@msn.com

Device Dimensions

• Height: 2 Meter
• Height: 2 Meter
• Height: 2 Meter
• Angle: 180 degree
• Length: 2.2 Meter
• Height: 2 Meter

Operating and Storage Conditions

• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 millibar and 701 millibar
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 100 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D881RXEMWEXP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160458

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-12

On-Brand Devices [BI Image-X]

• D881RXEPWEXP0: The BI IMAGE-X EVOLUTION® device is an extraoral x-ray generator that provides the radiation ne
• D881RXEMWEXP0: The BI IMAGE-X EVOLUTION® device is an extraoral x-ray generator that provides the radiation ne