Clearance Summary
PlutoX Digital Intraoral X-Ray Imaging System received FDA 510(k) clearance under submission number K210312, sponsored by Iray Technology Taicang , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2021-04-23.
- Submission: K210312
- Applicant / Sponsor: Iray Technology Taicang , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2021-04-23
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.