Clearance Summary
CAPIMAGE received FDA 510(k) clearance under submission number K081829, sponsored by Danish Diagnostic Development A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-07-11.
- Submission: K081829
- Applicant / Sponsor: Danish Diagnostic Development A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 2008-07-11
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.