Clearance Summary
ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT received FDA 510(k) clearance under submission number K863710, sponsored by Ausonics Pty , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1986-10-14.
- Submission: K863710
- Applicant / Sponsor: Ausonics Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1710
- Decision date: 1986-10-14
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.