Clearance Summary
VivaScope System received FDA 510(k) clearance under submission number K180162, sponsored by Caliber Imaging & Diagnostics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2018-05-03.
- Submission: K180162
- Applicant / Sponsor: Caliber Imaging & Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 2018-05-03
Classification & Regulation
This clearance is catalogued under FDA product code PSN and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.