- Physicians Office Resource

Invenia ABUS 2.0 Scan Station
Invenia - ABUS 2.0

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

Handling Environment Humidity - Percent (%) Relative Humidity

75.00
30.00

Handling Environment Temperature - Degrees Celsius

35.00
5.00

Special Storage Condition, Specify

Operating condition Altitude: 0 to 3000 meters

Special Storage Condition, Specify

Storing condition Altitude: 0 to 5000 meters

Storage Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Storage Environment Temperature - Degrees Celsius

60.00
-10.00

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 Identifiers

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

GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.