510(k) · Cleared
ClearedAvanti
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optovue, Inc. · OBO Tomography, Optical Coherence
Cleared on Jun 8, 2018 as substantially equivalent to K153080 (Optovue, Inc., 2016) and 1 other predicate after an 86-day review. Its family tree reaches back 8 generations to 2002. 5 later devices descend from it.
- Decided
- Jun 8, 2018
- Review
- 86 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K012727 (2002). 15 ancestors in all, the oldest K955442 (1996). 5 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 7 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 6 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 5 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 4 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 3 generations backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- 2 generations backK120238 Rtvue XR OctOptovue, Inc. · 2012
- 1 generation backK153080 RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
- This deviceK180660 AvantiOptovue, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK222166 SOLIXOptovue, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK213265 Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK251848 Pentacam® Cornea OCTOculus Optikgeräte GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK250553 Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation · 2025
- Descendant · cites it directly · 0 of its ownK221320 Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image…Nidek Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K222166SOLIXOptovue, Inc. · 2022 · cites it directly1descendant
- K213265Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation · 2022 · cites it directly1descendant
- K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH · 2026 · 2 generations on0descendants
- K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation · 2025 · 2 generations on0descendants
- K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −7 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −6 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −5 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −4 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −3 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| −2 | K120238 | Rtvue XR Oct | Optovue, Inc. | 2012 | — |
| −1 | K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016 | — |
| 0 (this device) | K180660 | Avanti | Optovue, Inc. | 2018 | — |
| +1 | K222166 | SOLIX | Optovue, Inc. | 2022 | — |
| +1 | K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 | Tomey Corporation | 2022 | — |
| +2 | K251848 | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | 2026 | — |
| +2 | K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | 2025 | — |
| +1 | K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing… | Nidek Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OBO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OBO device
- #1 K250868 SPECTRALIS HRA+OCT and variantsscore 16.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153080 | RTVue XR OCT Avanti with AngioVue SoftwareSummary page 4…e Devices Company Optovue, Inc. Devices 1) Optovue RTVue XR OCT Avanti with AngioVue Software (K153080) 2) Optovue RTVue CAM with Corneal Power Upgrade (K111505) Reference Device Company… | 2016 |
| * | K111505 | Rtvue Cam with Corneal Power UpgradeSummary page 4…Optovue RTVue XR OCT Avanti with AngioVue Software (K153080) 2) Optovue RTVue CAM with Corneal Power Upgrade (K111505) Reference Device Company Optovue, Inc. Device Optovue iVue (K163475) Indication… | 2011 |
| † | K163475 | iVue | 2017 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 15 ancestors have a recall of any class.
- Of its descendants, K222166 (Optovue, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K153080.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OBO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBO
125in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OBO
4in 2025
MAUDE reports naming product code OBO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 4 | 151 | 0 | 0 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 2 | — | 2 | 0 |
| 2012 | 3 | 269 | 2 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 3 | 152 | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 4 | 125 | 0 | 1 |
| 2017 | 4 | 118 | 0 | 0 |
| 2018 | 6 | 87 | 1 | 1 |
| 2019 | 5 | 249 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 1 |
| 2022 | 2 | — | 1 | 0 |
| 2023 | 7 | 262 | 0 | 3 |
| 2024 | 8 | 157 | 0 | 3 |
| 2025 | 3 | 125 | 0 | 4 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Avanti is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, corneal epithelia, corneal stroma, pachymetry, corneal power, and anterior chamber of the eye. With the integrated normative database, Avanti is also a quantitative tool…
Read the full statement (185 words)
The Avanti is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, corneal epithelia, corneal stroma, pachymetry, corneal power, and anterior chamber of the eye. With the integrated normative database, Avanti is also a quantitative tool for the comparison of retina, retinal nerve fiber layer, and optic disc measurements in the human eye to a database of a known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.
The Avanti with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects, and in subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects, and in subjects with glaucoma and retinal diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180660 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180660: Avanti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180660
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026