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510(k) K173689

Ophthalmic Software Platform RX by Canon Inc. -Medical Equipment Group — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2018
Date Received
December 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Management, Ophthalmic
Device Class
Class II
Regulation Number
892.2050
Review Panel
OP
Submission Type

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