Clearance Summary
IDX-60 INTRAORAL X-RAY received FDA 510(k) clearance under submission number K993958, sponsored by X-Cel X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-02-14.
- Submission: K993958
- Applicant / Sponsor: X-Cel X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2000-02-14
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.