Clearance Summary
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) received FDA 510(k) clearance under submission number K052422, sponsored by Flow X-Ray Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-09-27.
- Submission: K052422
- Applicant / Sponsor: Flow X-Ray Corp.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1810
- Decision date: 2005-09-27
Classification & Regulation
This clearance is catalogued under FDA product code EAP and 21 CFR 872.1810, within the Dental review panel as a Class II device.