Clearance Summary
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System received FDA 510(k) clearance under submission number K203578, sponsored by Perimeter Medical Imaging Ai, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-02-25.
- Submission: K203578
- Applicant / Sponsor: Perimeter Medical Imaging Ai, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2021-02-25
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.