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510(k) K122572

ICAM FUNDUS CAMERA by Optovue, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2013
Date Received
August 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

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  • K130656 — IFUSION (July 3, 2013)
  • K121739 — IVUE WITH NORMATIVE DATABASE (January 18, 2013)
  • K120238 — RTVUE XR OCT (April 3, 2012)
  • K111505 — RTVUE CAM WITH CORNEAL POWER UPGRADE (September 8, 2011)
  • K103266 — ISTAND (June 3, 2011)

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