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

Name: FDA 510(k) clearance K203578
Creator: U.S. Food and Drug Administration
Published: 2021-02-25

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.. Device class: 2.

Clearance details

Applicant: Perimeter Medical Imaging Ai, Inc.
Product code: Code NQQ
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2020-12-07
Decision date: 2021-02-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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