Clearance Summary
ULTRALITE X-RAY FILM ILLUMINATOR received FDA 510(k) clearance under submission number K922848, sponsored by A & S Trading 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 1992-09-28.
- Submission: K922848
- Applicant / Sponsor: A & S Trading Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1890
- Decision date: 1992-09-28
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.