Clearance Summary
SMART MOTORIZED VIEWER received FDA 510(k) clearance under submission number K973965, sponsored by Smartlight, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-12-12.
- Submission: K973965
- Applicant / Sponsor: Smartlight, Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1890
- Decision date: 1997-12-12
Classification & Regulation
This clearance is catalogued under FDA product code IXC and 21 CFR 892.1890, within the Radiology review panel as a Class I device.