Clearance Summary
OTIS Optical Coherence Tomography SYstem received FDA 510(k) clearance under submission number K190404, sponsored by Perimeter Medical Imaging, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-03-26.
- Submission: K190404
- Applicant / Sponsor: Perimeter Medical Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2019-03-26
Classification & Regulation
This clearance is catalogued under FDA product code NQQ and 21 CFR 892.1560, within the Radiology review panel as a Class II device.