510(k) · Cleared
ClearedScanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek Co., Ltd. · OBO Tomography, Optical Coherence
Cleared on Mar 30, 2023 as substantially equivalent to K180660 (Optovue, Inc., 2018) and 2 other predicates after a 328-day review. Its family tree reaches back 9 generations to 2002.
- Decided
- Mar 30, 2023
- Review
- 328 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K012727 (2002). 44 ancestors in all, the oldest K870039 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 5 generations between
- 3 generations backK120238 Rtvue XR OctOptovue, Inc. · 2012
- 2 generations backK153080 RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
- 1 generation backK180660 AvantiOptovue, Inc. · 2018
- This deviceK221320 Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image…Nidek Co., Ltd. · 2023
Show all 9 generations
- Root · 9 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 8 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 7 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 6 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 5 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 4 generations backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- 3 generations backK120238 Rtvue XR OctOptovue, Inc. · 2012
- 2 generations backK153080 RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
- 1 generation backK180660 AvantiOptovue, Inc. · 2018
- This deviceK221320 Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image…Nidek Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −8 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −7 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −6 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −5 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −4 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| −3 | K120238 | Rtvue XR Oct | Optovue, Inc. | 2012 | — |
| −2 | K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016 | — |
| −1 | K180660 | Avanti | Optovue, Inc. | 2018 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K180660 | AvantiSummary page 4…hthalmoscope Classification Regulation: 21 CFR 886.1570 Product Code: OBO, MYC, NFJ Predicate Devices Primary predicate: Avanti (K180660) Secondary predicate: P200DTx: (K142897) Image Filing Software NAVIS-EX: (K181345)… | 2018 |
| * | K142897 | P200DTxSummary page 4…21 CFR 886.1570 Product Code: OBO, MYC, NFJ Predicate Devices Primary predicate: Avanti (K180660) Secondary predicate: P200DTx: (K142897) Image Filing Software NAVIS-EX: (K181345)… | 2015 |
| * | K181345 | Image Filing Software NAVIS-EXSummary page 4…Devices Primary predicate: Avanti (K180660) Secondary predicate: P200DTx: (K142897) Image Filing Software NAVIS-EX: (K181345) Page 1… | 2018 |
| † | K113451 | Non-Mydriatic Auto Fundus Camera Afc-330 with Image Filing Software NA Vis-EX | 2012 |
| † | K163564 | Slit Lamp SL-2000 | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 44 ancestors have a recall of any class.
- 2 other devices also cite its predicate K180660.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] The Mirante SLO/OCT with scanning laser ophthalmoscope and optical coherence tomography function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of: • the retina, retinal nerve fiber layer, optic disc, and • the anterior chamber and cornea (when used…
Read the full statement (228 words)
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model]
The Mirante SLO/OCT with scanning laser ophthalmoscope and optical coherence tomography function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:
• the retina, retinal nerve fiber layer, optic disc, and
• the anterior chamber and cornea (when used with the optional anterior segment OCT adapter)
and for color, angiography, autofluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.
Scanning Laser Ophthalmoscope Mirante [SLO Model]
The Mirante SLO with scanning laser ophthalmoscope function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus. It is indicated for color, angiography, auto-fluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221320: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221320
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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