Clearance Summary
PLATINUM DRF IMAGING SYSTEM received FDA 510(k) clearance under submission number K131766, sponsored by Apelem-Dms Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-12-12.
- Submission: K131766
- Applicant / Sponsor: Apelem-Dms Group
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2013-12-12
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.