510(k) · Cleared
Recalled · Class II · 2024IMAGEnet6 Ophthalmic Data System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Corporation · NFJ System, Image Management, Ophthalmic
Cleared on Mar 1, 2024 as substantially equivalent to K171370 (Topcon Corporation, 2017) after a 170-day review. Its family tree reaches back 9 generations to 2002. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 1, 2024
- Review
- 170 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K012727 (2002). 24 ancestors in all, the oldest K946058 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 5 generations between
- 3 generations backK121739 Ivue with Normative DatabaseOptovue, Inc. · 2013 · Recalled
- 2 generations backK161509 3D OCT-1 MaestroTopcon Corporation · 2016
- 1 generation backK171370 IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation · 2017 · Recalled
- This deviceK232828 IMAGEnet6 Ophthalmic Data SystemTopcon Corporation · 2024
- Descendant · cites it directly · 1 of its ownK241081 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6…Topcon Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK253893 Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy · 2026
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 backK091404 Ivue, Model 100Optovue, Inc. · 2010 · Recalled
- 3 generations backK121739 Ivue with Normative DatabaseOptovue, Inc. · 2013 · Recalled
- 2 generations backK161509 3D OCT-1 MaestroTopcon Corporation · 2016
- 1 generation backK171370 IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation · 2017 · Recalled
- This deviceK232828 IMAGEnet6 Ophthalmic Data SystemTopcon Corporation · 2024
Most influential descendants
Showing 2 of 2 · See allView 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 | K091404 | Ivue, Model 100 | Optovue, Inc. | 2010 | 2 |
| −3 | K121739 | Ivue with Normative Database | Optovue, Inc. | 2013 | 3 |
| −2 | K161509 | 3D OCT-1 Maestro | Topcon Corporation | 2016 | — |
| −1 | K171370 | IMAGEnet 6 Ophthalmic Data System | Topcon Corporation | 2017 | 1 |
| 0 (this device) | K232828 | IMAGEnet6 Ophthalmic Data System | Topcon Corporation | 2024 | — |
| +1 | K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6… | Topcon Corporation | 2024 | — |
| +2 | K253893 | Harmony Referral System with Harmony OCT Viewer (Octave) | Topcon Healthcare Solutions EMEA Oy | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 NFJ? 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 NFJ device
- #1 K260694 Zeiss Clinic 360score 15.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K171370 | IMAGEnet 6 Ophthalmic Data SystemSummary page 4…FJ PREDICATE DEVICE: IMAGEnet6 Ophthalmic Data System: Company Topcon Corporation Device IMAGEnet6 Ophthalmic Data System 510(k) No. K171370 Classification Name: 21 C.F.R. § 892.2050 Topcon Corporation Page 1 of 6… | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data… | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 17, 2024 | Class II | Z-0362-2025 | Software design | The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 24 ancestors have a recall of any class.
- Of its descendants, K241081 (Topcon Corporation, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NFJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NFJ
85in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFJ
2in 2022
MAUDE reports naming product code NFJ, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 67 | 0 | 0 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 73 | 0 | 6 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 87 | 1 | 2 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 5 | 175 | 0 | 4 |
| 2018 | 7 | 84 | 0 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 5 | 116 | 2 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 284 | 1 | 2 |
| 2023 | 4 | 85 | 0 | 0 |
| 2024 | 2 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The IMAGEnet6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and
management of digital images, patient data, diagnostic data and clinical information from Topcon devices.
It is intended for processing and displaying ophthalmic images and optical coherence tomography data.
The IMAGEnet6 Ophthalmic Data System uses the same algorithms and reference databases from the original data
capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal
subjects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232828 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232828: IMAGEnet6 Ophthalmic Data System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232828
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