Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes such as biopsy, pre-surgerical localization or treatment devices.

Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes such as biopsy, pre
AFFIRM™ CONTRAST BIOPSY - AFFIRM™ CONTRAST BIOPSY SOFTWARE

An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: IZH

Device Name: System, X-Ray, Mammographic

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: 892.1710

Third Party Flag: Y

Medical Specialty: RA

Device Id: 15420045512948

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