510(k) · Cleared
ClearedZeiss Clinic 360
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · NFJ System, Image Management, Ophthalmic
Cleared on Jul 17, 2026 as substantially equivalent to K232555 (Topcon Healthcare Solutions, 2023) after a 136-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Jul 17, 2026
- Review
- 136 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K896095 (1990). 20 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 backK232555 HarmonyTopcon Healthcare Solutions · 2023
- This deviceK260694 Zeiss Clinic 360Carl Zeiss Meditec, AG · 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 backK232555 HarmonyTopcon Healthcare Solutions · 2023
- This deviceK260694 Zeiss Clinic 360Carl Zeiss Meditec, AG · 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 | K232555 | Harmony | Topcon Healthcare Solutions | 2023 | — |
| 0 (this device) | K260694 | Zeiss Clinic 360 | Carl Zeiss Meditec, AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 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 K253893 Harmony Referral System with Harmony OCT…score 14.7 · 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 |
|---|---|---|---|
| * | K232555 | HarmonySummary page 5…892.2050 Product Code(s): NFJ 3.0 Legally Marketed Predicate Devices Predicate # - Predicate Tade Name (Primary Predicate is listed first) – Product Code K232555 – Harmony – NFJ K233933 – CIRRUS™ HD-OCT Model 6000 – OBO K093213 – GPA on the HUMPHREY FIELD ANALYZER II & II-I Series – HPT 4… | 2023 |
| † | K233933 | CIRRUS™ HD-OCT Model 6000 | 2024 |
| † | K093213 | Guided Progression Analysis on the Humphrey Field Analyzer II and II -I Series | 2010 |
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.
- 1 of the 20 ancestors has 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?
ZEISS CLINIC 360 is comprehensive software intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management and display of patient data, diagnostic data, clinical information, and reports from ophthalmic diagnostic instruments through computerized networks.
The device aids in the detection, monitoring and management of various ocular diseases.
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/K260694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260694: Zeiss Clinic 360.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260694
Report an extraction error
Are you the manufacturer?
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