Clearance Summary
QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) received FDA 510(k) clearance under submission number K993763, sponsored by Medis Medical Imaging Systems BV. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-11-26.
- Submission: K993763
- Applicant / Sponsor: Medis Medical Imaging Systems BV
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1600
- Decision date: 1999-11-26
Classification & Regulation
This clearance is catalogued under FDA product code IZI and 21 CFR 892.1600, within the Radiology review panel as a Class II device.