OTIS Optical Coherence Tomography System— 510(k) K171560

Name: FDA 510(k) clearance K171560
Creator: U.S. Food and Drug Administration
Published: 2017-08-25

Unknown

Perimeter Medical Imaging, Inc.

FDA 510(k) clearance K171560 for OTIS Optical Coherence Tomography System, Unknown on 2017-08-25. 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: 2017-05-30
Decision date: 2017-08-25
Decision: Unknown
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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