Ophthalmic Software Platform RX— 510(k) K173689

Name: FDA 510(k) clearance K173689
Creator: U.S. Food and Drug Administration
Published: 2018-02-23

Substantially Equivalent

Canon Inc. -Medical Equipment Group

FDA 510(k) clearance K173689 for Ophthalmic Software Platform RX, Substantially Equivalent on 2018-02-23. Applicant: Canon Inc. -Medical Equipment Group. Device class: 2.

Clearance details

Applicant: Canon Inc. -Medical Equipment Group
Product code: Code NFJ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2017-12-01
Decision date: 2018-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nakahara-Ku, Kawasaki, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.