RTVue XR OCT Avanti with AngioVue Software
FDA 510(k) K153080 · Optovue, Inc.
510(k) numberK153080
Submission
- Device name
- RTVue XR OCT Avanti with AngioVue Software
- Applicant
- Optovue, Inc.
Fremont, CA, US - Received
- October 23, 2015
- Decision date
- February 11, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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|---|---|---|---|
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| K142953 | OCT-CameraHLI · Traditional | Optomedical Technologies GmbH | 03/04/2015SE |
| K141638 | Propper Insight Binocular Indirect OphthalmosopeHLI · Abbreviated | Propper Manufacturing Co., Inc. | 09/17/2014SE |
| K133758 | Centervue Macular Integrity AssessmentHLI · Traditional | Centervue S.P.A. | 04/23/2014SE |
| K131939 | Amico DH-W35 Ophthalmoscope SeriesHLI · Traditional | Amico Diagnostic Incorporated | 03/26/2014SE |
| K133892 | Ivue 500HLI · Traditional | Optovue, Inc. | 03/19/2014SE |
| K123316 | Heine Omega 500HLI · Abbreviated | Heine Optotechnik GmbH & Co. KG | 02/26/2013SE |
| K121739 | Ivue with Normative DatabaseHLI · Traditional | Optovue, Inc. | 01/18/2013SE |
| K120057 | Envisu Spectral Domain Ophthalmic Imaging System (Sdois)HLI · Traditional | Bioptigen, Inc. | 05/11/2012SE |
| K120238 | Rtvue XR OctHLI · Special | Optovue, Inc. | 04/03/2012SE |
More from Optovue, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K222166 | SolixOBO · Traditional | 11/09/2022SE |
| K180660 | AvantiOBO · Traditional | 06/08/2018SE |
| K163475 | iVueOBO · Traditional | 06/09/2017SE |
| K133892 | Ivue 500HLI · Traditional | 03/19/2014SE |
| K130656 | IfusionHKI · Special | 07/03/2013SE |
| K121739 | Ivue with Normative DatabaseHLI · Traditional | 01/18/2013SE |
| K122572 | Icam Fundus CameraHKI · Traditional | 01/11/2013SE |
| K120238 | Rtvue XR OctHLI · Special | 04/03/2012SE |
| K111505 | Rtvue Cam with Corneal Power UpgradeOBO · Traditional | 09/08/2011SE |
| K103266 | IstandHLI · Traditional | 06/03/2011SE |
Questions and answers
When was RTVue XR OCT Avanti with AngioVue Software cleared by the FDA?
RTVue XR OCT Avanti with AngioVue Software (K153080) received a 510(k) decision of Substantially Equivalent on February 11, 2016, 111 days after the submission was received.
What is the product code of K153080?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.