Clearance Summary
Cydar EV received FDA 510(k) clearance under submission number K160088, sponsored by Cydar , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-07-07.
- Submission: K160088
- Applicant / Sponsor: Cydar , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2016-07-07
Classification & Regulation
This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.