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510(k) K072971

TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS by Topcon Medical Systems, Inc. — Product Code OBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2009
Date Received
October 22, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tomography, Optical Coherence
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

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