Invenia - ABUS Review Software
Device Description
An assembly of electrically-powered devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the ability to give reproducible images of the breast. It typically includes software packages that support a variety of static or real-time breast specific imaging used primarily for oncology. It will generate ultrasound pulses, direct them to the target area, detect the ultrasound echoes, and process the resulting information to produce and display static or dynamic two- or three-dimensional (3-D) images.
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: PAA
Device Name: Automated Breast Ultrasound
Device Class: 3
Physical State: May include different transducers
Definition: Adjunct to mammography for breast cancer screening and diagnosis.
Submission Type ID: 2
Review Panel: RA
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Uses an automatic method of acquiring ultrasound images of the breast
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Breast
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 00840682100090
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