Clearance Summary
HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW received FDA 510(k) clearance under submission number K933058, sponsored by Heartware Intl. Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1993-09-28.
- Submission: K933058
- Applicant / Sponsor: Heartware Intl. Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1600
- Decision date: 1993-09-28
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.