510(k) K091404

IVUE, MODEL 100 by Optovue, Inc. — Product Code OBO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 22, 2010
Date Received: May 12, 2009
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.

Other clearances by Optovue, Inc.

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K133892 — IVUE 500 (March 19, 2014)
K130656 — IFUSION (July 3, 2013)
K121739 — IVUE WITH NORMATIVE DATABASE (January 18, 2013)
K122572 — ICAM FUNDUS CAMERA (January 11, 2013)
K120238 — RTVUE XR OCT (April 3, 2012)
K111505 — RTVUE CAM WITH CORNEAL POWER UPGRADE (September 8, 2011)

Other clearances for product code OBO

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