BladderScan® - Prime
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 IdentifiersDevice Id: 10879123005493
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00879123005496
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 00879123005496
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