Clearance Summary
VOXAR 3D ENTERPRISE WITH CARDIAMETRIX received FDA 510(k) clearance under submission number K061326, sponsored by Barcoview Mis Edinburgh. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-05-25.
- Submission: K061326
- Applicant / Sponsor: Barcoview Mis Edinburgh
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2006-05-25
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.