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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
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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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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