OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System— 510(k) K203578

Substantially Equivalent

Perimeter Medical Imaging Ai, Inc.

FDA 510(k) clearance K203578 for OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System, Substantially Equivalent on 2021-02-25. Applicant: Perimeter Medical Imaging Ai, Inc..

Clearance details

Applicant: Perimeter Medical Imaging Ai, Inc.
Product code: Code NQQ
Advisory panel: Radiology
Date received: 2020-12-07
Decision date: 2021-02-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

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