Clearance Summary
3DHJD CAMERA SYSTEM MODEL received FDA 510(k) clearance under submission number K101810, sponsored by Vision Systems Group, A Division of Viking Systems. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2010-08-30.
- Submission: K101810
- Applicant / Sponsor: Vision Systems Group, A Division of Viking Systems
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2010-08-30
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.