Invenia

Invenia - ABUS 2.0

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00840682141161

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