Clearance Summary
Platinum dRF Imaging System received FDA 510(k) clearance under submission number K160301, sponsored by Apelem-Dms Group. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-03-04.
- Submission: K160301
- Applicant / Sponsor: Apelem-Dms Group
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2016-03-04
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.