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510(k) K132438

IMAGENET 5 PC SOFTWARE SYSTEM by Topcon Medical Systems, Inc. — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2013
Date Received
August 5, 2013
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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  • K072971 — TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINA (January 13, 2009)
  • K031831 — TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (December 19, 2003)

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