510(k) K083316

3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM by Topcon Medical Systems, Inc. — Product Code OBO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 13, 2009
Date Received: November 10, 2008
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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