Clearance Summary
PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner received FDA 510(k) clearance under submission number K151053, sponsored by Sopro - Acteon Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-07-31.
- Submission: K151053
- Applicant / Sponsor: Sopro - Acteon Group
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2015-07-31
Classification & Regulation
This clearance is catalogued under FDA product code MUH and 21 CFR 872.1800, within the Dental review panel as a Class II device.