Clearance Summary
Affirm Contrast Biopsy received FDA 510(k) clearance under submission number K202294, sponsored by Hologic, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-10-05.
- Submission: K202294
- Applicant / Sponsor: Hologic, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1710
- Decision date: 2020-10-05
Classification & Regulation
This clearance is catalogued under FDA product code IZH and 21 CFR 892.1710, within the Radiology review panel as a Class II device.