Clearance Summary
4D MV-ASSESSMENT 2.0 received FDA 510(k) clearance under submission number K103782, sponsored by Tomtec Imaging Systems GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-01-27.
- Submission: K103782
- Applicant / Sponsor: Tomtec Imaging Systems GmbH
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2011-01-27
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.