Clearance Summary
ClarifEye R1.0, ClarifEye Needle received FDA 510(k) clearance under submission number K201743, sponsored by Philips Medical Systems Nederlands B.V.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-02-23.
- Submission: K201743
- Applicant / Sponsor: Philips Medical Systems Nederlands B.V.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2021-02-23
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.