Clearance Summary
LILY DARK VIEWER received FDA 510(k) clearance under submission number K954998, sponsored by Lily Imaging Solutions Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-01-29.
- Submission: K954998
- Applicant / Sponsor: Lily Imaging Solutions Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1890
- Decision date: 1996-01-29
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.