Clearance Summary
DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) received FDA 510(k) clearance under submission number K992896, sponsored by Dental X-Ray Support Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-09-03.
- Submission: K992896
- Applicant / Sponsor: Dental X-Ray Support Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1900
- Decision date: 1999-09-03
Classification & Regulation
This clearance is catalogued under FDA product code EGY and 21 CFR 892.1900, within the Radiology review panel as a Class II device.