OTIS Optical Coherence Tomography SYstem— 510(k) K190404

Name: FDA 510(k) clearance K190404
Creator: U.S. Food and Drug Administration
Published: 2019-03-26

Substantially Equivalent

Perimeter Medical Imaging, Inc.

FDA 510(k) clearance K190404 for OTIS Optical Coherence Tomography SYstem, Substantially Equivalent on 2019-03-26. Applicant: Perimeter Medical Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Perimeter Medical Imaging, Inc.
Product code: Code NQQ
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2019-02-19
Decision date: 2019-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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