Clearance Summary
IRIS INTELLIGENT RETINAL IMAGING SYSTEM received FDA 510(k) clearance under submission number K141922, sponsored by Intelligent Retinal Imaging Systems, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2015-02-27.
- Submission: K141922
- Applicant / Sponsor: Intelligent Retinal Imaging Systems, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2015-02-27
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.