Clearance Summary
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I received FDA 510(k) clearance under submission number K040443, sponsored by Dome Imaging Systems, 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 2004-06-16.
- Submission: K040443
- Applicant / Sponsor: Dome Imaging Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2004-06-16
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.