Clearance Summary
MODEL MPFT-01, GENESIS received FDA 510(k) clearance under submission number K934574, sponsored by International Medical Designs, 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 1994-03-04.
- Submission: K934574
- Applicant / Sponsor: International Medical Designs, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1994-03-04
Classification & Regulation
This clearance is catalogued under FDA product code IXR and 21 CFR 892.1980, within the Radiology review panel as a Class II device.