Clearance Summary
CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER received FDA 510(k) clearance under submission number K915715, 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 1992-07-02.
- Submission: K915715
- Applicant / Sponsor: Ausonics Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1992-07-02
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.