Clearance Summary
DIGI-LITE TCD DEVICE received FDA 510(k) clearance under submission number K062578, 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 2006-09-18.
- Submission: K062578
- Applicant / Sponsor: Rimed , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2006-09-18
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.