FDA 510(k), K153080, RTVue XR OCT Avanti with AngioVue Software

FDA 510(k), K153080, RTVue XR OCT Avanti with AngioVue Software

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510(K) Number: K153080
Device Name: RTVue XR OCT Avanti with AngioVue Software
Manufacturer: EDWARD SINCLAIR
Device Classification Name: Ophthalmoscope, Ac-Powered
Regulation Number: HLI
Classification Product Code: KXA
Date Received: 10/23/2015
Decision Date: 02/11/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic

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