Clearance Summary
Prelude received FDA 510(k) clearance under submission number K180308, sponsored by Medcom 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 2018-03-27.
- Submission: K180308
- Applicant / Sponsor: Medcom GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2018-03-27
Classification & Regulation
This clearance is catalogued under FDA product code MUJ and 21 CFR 892.5050, within the Radiology review panel as a Class II device.