Product Overview

Voluson - E8 BT16


Device Description

A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.


Environmental Conditions

  • Handling Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 64.00
  • Handling Environment Temperature - Degrees Celsius
    • 30.00
    • 18.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 104.00
    • 14.00
  • Storage Environment Temperature - Degrees Celsius
    • 40.00
    • -10.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: ITX

    Device Name: Transducer, Ultrasonic, Diagnostic

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: RA

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 892.1570

    Third Party Flag: Y

    Medical Specialty: RA


    Code: IYO

    Device Name: System, Imaging, Pulsed Echo, Ultrasonic

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: RA

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 892.1560

    Third Party Flag: Y

    Medical Specialty: RA


    Code: IYN

    Device Name: System, Imaging, Pulsed Doppler, Ultrasonic

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: RA

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 892.1550

    Third Party Flag: Y

    Medical Specialty: RA


    Device Identifiers

    Device Id: 00840682100137

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    Educational Resources
    Videos