510(k) · Cleared
ClearedHarmony Referral System with Harmony OCT Viewer (Octave)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Healthcare Solutions EMEA Oy · NFJ System, Image Management, Ophthalmic
Cleared on Jun 4, 2026 as substantially equivalent to K210396 (Topcon Healthcare Solutions EMEA Oy, 2021) and 1 other predicate after a 182-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Jun 4, 2026
- Review
- 182 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K896095 (1990). 61 ancestors in all, the oldest K870039 (1987). No later device cites it as a predicate yet.
- Root · 12 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations between
- 3 generations backK151952 Synergy ODMTopcon Medical Systems, Inc. · 2015
- 2 generations backK182376 HarmonyTopcon Medical Systems, Inc. · 2018
- 1 generation backK210396 Harmony Referral SystemTopcon Healthcare Solutions EMEA Oy · 2021
- This deviceK253893 Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy · 2026
Show all 12 generations
- Root · 12 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 11 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 10 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 9 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 8 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 7 generations backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- 6 generations backK093313 SynergyTopcon Medical Systems, Inc. · 2009
- 5 generations backK122938 Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · Recalled
- 4 generations backK132667 Synergy OdmTopcon Medical Systems, Inc. · 2013
- 3 generations backK151952 Synergy ODMTopcon Medical Systems, Inc. · 2015
- 2 generations backK182376 HarmonyTopcon Medical Systems, Inc. · 2018
- 1 generation backK210396 Harmony Referral SystemTopcon Healthcare Solutions EMEA Oy · 2021
- This deviceK253893 Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −11 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −10 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −9 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −8 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −7 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| −6 | K093313 | Synergy | Topcon Medical Systems, Inc. | 2009 | — |
| −5 | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist Match | Carl Zeiss Meditec, AG | 2012 | 1 |
| −4 | K132667 | Synergy Odm | Topcon Medical Systems, Inc. | 2013 | — |
| −3 | K151952 | Synergy ODM | Topcon Medical Systems, Inc. | 2015 | — |
| −2 | K182376 | Harmony | Topcon Medical Systems, Inc. | 2018 | — |
| −1 | K210396 | Harmony Referral System | Topcon Healthcare Solutions EMEA Oy | 2021 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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? (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 |
|---|---|---|---|
| * | K210396 | Harmony Referral SystemSummary page 5…Date Prepared: June 01, 2026 Trade Name of Device Harmony Referral System 3.12 with Harmony OCT Viewer 1.0 Primary Predicate Device Topcon Harmony Referral System (K210396) Primary Predicate and Subject Device Classification Information Regulation Number: 21 CFR 892.2050 Classification name: Medic… | 2021 |
| * | K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Summary page 5…ss II Common name: System, Image Management, Ophthalmic Product Codes, Name: NFJ Secondary Predicate Device Topcon Corporation IMAGEnet6 Ophthalmic Data System (K241081) Secondary Predicate Device Classification Information Regulation Number: 21 CFR 892.2050 Classification name: Medical image m… | 2024 |
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 36 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- 11 of the 61 ancestors have a recall of any class.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Harmony Referral System (Harmony RS) is a comprehensive software platform intended for use in importing, processing, viewing, measurement and storage of clinical images and videos as well as in management and communication of patient data, diagnostic and clinical information and reports from ophthalmic diagnostic instruments through either direct connection with the instruments or through computerized networks. The system neither performs any…
Read the full statement (188 words)
Harmony Referral System (Harmony RS) is a comprehensive software platform intended for use in importing, processing, viewing, measurement and storage of clinical images and videos as well as in management and communication of patient data, diagnostic and clinical information and reports from ophthalmic diagnostic instruments through either direct connection with the instruments or through computerized networks. The system neither performs any interpretations nor provides treatment recommendations.
The optional Harmony OCT Viewer module extends the indications with:
Harmony OCT viewer is intended for processing, viewing, analyzing, and providing measurements of clinical optical coherence tomography (OCT) and fundus images from any OCT acquisition device, in conjunction with the Harmony RS as a medical image communication system. It is not intended to provide treatment recommendations.
Harmony OCT viewer is indicated to be used as an aid in
diagnosis and
monitoring
by quantitative assessment of anatomic structures in the eye for various diseases.
For Topcon OCT devices, it uses reference databases from the original data capture device as a quantitative tool for the comparison to normal subjects.
Harmony OCT Viewer does not, in itself, provide diagnoses or perform treatment or active monitoring.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253893: Harmony Referral System with Harmony OCT Viewer (Octave).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253893
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026