Clearance Summary
AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION received FDA 510(k) clearance under submission number K920307, 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 1992-05-19.
- Submission: K920307
- Applicant / Sponsor: Ausonics Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 1992-05-19
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.