Clearance Summary
MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN received FDA 510(k) clearance under submission number K913463, sponsored by Bruker Medical Imaging, 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 1991-11-29.
- Submission: K913463
- Applicant / Sponsor: Bruker Medical Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 1991-11-29
Classification & Regulation
This clearance is catalogued under FDA product code LNH and 21 CFR 892.1000, within the Radiology review panel as a Class II device.