Clearance Summary
DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN received FDA 510(k) clearance under submission number K905488, 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 1991-12-18.
- Submission: K905488
- Applicant / Sponsor: Ausonics Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2010
- Decision date: 1991-12-18
Classification & Regulation
This clearance is catalogued under FDA product code LMB and 21 CFR 892.2010, within the Radiology review panel as a Class I device.