Clearance Summary
CARDIAC VIEW, MODEL 2001 received FDA 510(k) clearance under submission number K010513, sponsored by Magna-Lab, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-05-21.
- Submission: K010513
- Applicant / Sponsor: Magna-Lab, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2001-05-21
Classification & Regulation
This clearance is catalogued under FDA product code MOS and 21 CFR 892.1000, within the Radiology review panel as a Class II device.