Identifiers
- 510(k) Number
- K202294 FDA 510(k)
- FDA Product Code
- IZH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1710 FDA 510(k)
- Regulation Number
- 892.1710 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Affirm Contrast Biopsy is a software application designed to assist clinicians in targeting and acquiring tissue samples from lesions identified during contrast-enhanced mammography. It functions as an optional software license for use with the Selenia Dimensions and 3Dimensions mammographic systems.
This software is intended for use in conjunction with the I-View contrast-enhanced mammography biopsy software and the Affirm breast biopsy guidance system. The device is regulated under FDA 510(k) clearance as a mammographic X-ray system component.
Frequently asked questions
What is the primary function of the Affirm Contrast Biopsy?
This software application is designed to assist clinicians in the precise targeting and acquisition of tissue samples from lesions that have been identified during contrast-enhanced mammography procedures.
Which mammography systems are compatible with this software?
The Affirm Contrast Biopsy functions as an optional software license specifically for use with Hologic Selenia Dimensions and 3Dimensions mammographic systems.
Does this software require other systems to operate?
Yes, the software is intended to be used in conjunction with the I-View contrast-enhanced mammography biopsy software and the Affirm breast biopsy guidance system to ensure proper functionality.
What is the regulatory status of this device?
The Affirm Contrast Biopsy is regulated under FDA 510(k) clearance as a mammographic X-ray system component, specifically classified as a class 2 device under regulation number 892.1710.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Affirm® Contrast Biopsy Software | Enhanced Visualization | Hologic, Hologic Obtains CE Mark for Affirm® Contrast Biopsy Software | Hologic, Affirm® Contrast Biopsy Software | Hologic® UK
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202294 | Class II | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA 510(k) K202294 24 fields · synced Sep 21, 2026