BladderScan®


Product Overview

BladderScan® - Tissue-Equivalent Phantom


Device Description

An instrument used for quality assurance (QA) purposes to check the calibration and performance of systems that produce ultrasound waves used for diagnostic or therapeutic applications. This includes a variety of instruments used to measure parameters associated with beam production, beam quality, image quality and other system performance parameters.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

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


Device Identifiers

Device Id: 10879123001969

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00879123001962

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A


Device Id: 00879123001962

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


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