Clearance Summary
ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT received FDA 510(k) clearance under submission number K883372, 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 1988-11-25.
- Submission: K883372
- Applicant / Sponsor: Ausonics Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1988-11-25
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.