Clearance Summary
EyeSuite Imaging received FDA 510(k) clearance under submission number K142423, sponsored by Haag-Streit AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-09-10.
- Submission: K142423
- Applicant / Sponsor: Haag-Streit AG
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2014-09-10
Classification & Regulation
This clearance is catalogued under FDA product code NFJ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.