Clearance Summary
CSL X-RAY IMAGESCOPE received FDA 510(k) clearance under submission number K923137, sponsored by Csi Opto-Electronics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1992-09-23.
- Submission: K923137
- Applicant / Sponsor: Csi Opto-Electronics Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1992-09-23
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.