Clearance Summary
MEDIMAGE received FDA 510(k) clearance under submission number K972215, sponsored by Vepro - Computersysteme GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-11-19.
- Submission: K972215
- Applicant / Sponsor: Vepro - Computersysteme GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1997-11-19
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.