Clearance Summary
DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST received FDA 510(k) clearance under submission number K883317, sponsored by S & S X-Ray Products, 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 1989-04-26.
- Submission: K883317
- Applicant / Sponsor: S & S X-Ray Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5710
- Decision date: 1989-04-26
Classification & Regulation
This clearance is catalogued under FDA product code IXI and 21 CFR 892.5710, within the Radiology review panel as a Class II device.