iVue
FDA 510(k) K163475 · Optovue, Inc.
510(k) numberK163475
Submission
- Device name
- iVue
- Applicant
- Optovue, Inc.
Fremont, CA, US - Received
- December 12, 2016
- Decision date
- June 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBO – Tomography, Optical Coherence
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Other 510(k)s with product code OBO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261019 | AnterionOBO · Traditional | Heidelberg Engineering GmbH | 09/11/2026SE |
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleOBO · Traditional | Heidelberg Engineering GmbH | 05/07/2026SE |
| K252633 | Unity DX (Udx)OBO · Traditional | Cylite Pty. , Ltd. | 12/23/2025SE |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2)OBO · Traditional | Tomey Corporation | 07/18/2025SE |
| K250868 | SPECTRALIS HRA+OCT and variantsOBO · Traditional | Heidelberg Engineering GmbH | 05/12/2025SE |
| K240924 | AnterionOBO · Traditional | Heidelberg Engineering GmbH | 12/13/2024SE |
| K241163 | SPECTRALIS with Flex ModuleOBO · Traditional | Heidelberg Engineering GmbH | 10/11/2024SE |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…OBO · Traditional | Topcon Corporation | 07/17/2024SE |
| K240221 | SPECTRALIS HRA+OCT and variantsOBO · Traditional | Heidelberg Engineering GmbH | 07/01/2024SE |
| K233933 | CIRRUS HD-OCT Model 6000OBO · Traditional | Carl Zeiss Meditec, Inc. | 05/17/2024SE |
More from Carl Zeiss Meditec, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K222166 | SolixOBO · Traditional | 11/09/2022SE |
| K180660 | AvantiOBO · Traditional | 06/08/2018SE |
| K153080 | RTVue XR OCT Avanti with AngioVue SoftwareHLI · Traditional | 02/11/2016SE |
| 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 iVue cleared by the FDA?
iVue (K163475) received a 510(k) decision of Substantially Equivalent on June 9, 2017, 179 days after the submission was received.
What is the product code of K163475?
The FDA product code is OBO – Tomography, Optical Coherence, a Class II (moderate risk) device regulated under 21 CFR 886.1570.