Product Overview

N/A - PV-BBVC/12

Device Description

A dedicated computerized radiology information system (RIS) designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and generation of work lists for specific radiological systems, and in conjunction with a picture archiving and communication system (PACS). The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

Environmental Conditions

No Data Available

Device Sizes

  • Length: 12.0 Feet
    • Length: 12.0 Feet

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: OUG

    Device Name: Medical Device Data System

    Device Class: 1

    Physical State: Software and Electronics

    Definition: A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.

    Submission Type ID: 4

    Review Panel: HO

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Software algorithms to perform necessary medical communication functions

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Hospital Information Systems

    Regulation Number: 880.6310

    Third Party Flag: N

    Medical Specialty: HO

    Device Identifiers

    Device Id: 04961333244201

    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