Clearance Summary
Digi-One received FDA 510(k) clearance under submission number K143476, sponsored by Rimed , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2015-06-23.
- Submission: K143476
- Applicant / Sponsor: Rimed , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2015-06-23
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.