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510(k) K130656

IFUSION by Optovue, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2013
Date Received
March 12, 2013
Clearance Type
Special
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

Other clearances by Optovue, Inc.

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  • K153080 — RTVue XR OCT Avanti with AngioVue Software (February 11, 2016)
  • K133892 — IVUE 500 (March 19, 2014)
  • 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)
  • K103266 — ISTAND (June 3, 2011)

Other clearances for product code HKI

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  • K231230 — Optina-4C (MHRC-C1N) (December 5, 2023)
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