Clearance Summary
CP 100/30 received FDA 510(k) clearance under submission number K953292, sponsored by Micro-Focus Imaging., 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 1995-11-22.
- Submission: K953292
- Applicant / Sponsor: Micro-Focus Imaging., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 1995-11-22
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.