510(k) · Cleared
ClearedFORUM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · NFJ System, Image Management, Ophthalmic
Cleared on Mar 25, 2009 as substantially equivalent to K013694 (Nidek, Inc., 2002) after a 33-day review. Its family tree reaches back 5 generations to 1990. 32 later devices descend from it.
- Decided
- Mar 25, 2009
- Review
- 33 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K896095 (1990). 8 ancestors in all. 32 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 4 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 3 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 2 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 1 generation backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- This deviceK090439 FORUMCarl Zeiss Meditec, Inc. · 2009
- Descendant · cites it directly · 25 of its ownK122938 Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · Recalled
- Descendant · 2 generations on · 9 of its ownK132667 Synergy OdmTopcon Medical Systems, Inc. · 2013
- Descendant · 3 generations on · 8 of its ownK151952 Synergy ODMTopcon Medical Systems, Inc. · 2015
- Descendant · 4 generations on · 4 of its ownK182376 HarmonyTopcon Medical Systems, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK113696 Optos AdvanceOptos Plc. · 2012
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K122938Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · cites it directly25descendants
- K132667Synergy OdmTopcon Medical Systems, Inc. · 2013 · 2 generations on9descendants
- K151952Synergy ODMTopcon Medical Systems, Inc. · 2015 · 3 generations on8descendants
- K182376HarmonyTopcon Medical Systems, Inc. · 2018 · 4 generations on4descendants
- K113696Optos AdvanceOptos Plc. · 2012 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −4 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −3 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −2 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −1 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| 0 (this device) | K090439 | FORUM | Carl Zeiss Meditec, Inc. | 2009 | — |
| +1 | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist Match | Carl Zeiss Meditec, AG | 2012 | 1 |
| +2 | K132667 | Synergy Odm | Topcon Medical Systems, Inc. | 2013 | — |
| +3 | K151952 | Synergy ODM | Topcon Medical Systems, Inc. | 2015 | — |
| +4 | K182376 | Harmony | Topcon Medical Systems, Inc. | 2018 | — |
| +1 | K113696 | Optos Advance | Optos Plc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K013694 | Nidek Advanced Vision Information System (Navis)Summary page 1…FORUM T M PREDICATE DEVICE Company: Nidek, Inc. Device: Nidek Advanced Vision Information System (NAVIS) (K013694) 5 10(k) Premarket Notification FORU… | 2002 |
What descends from it? (32)
See all 325 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 19 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K122938 (Carl Zeiss Meditec, AG, 2012) has gone furthest, with 25 descendants of its own.
- 6 other devices also cite its predicate K013694.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
FORUM is a software system application intended for use in storing, managing, and
displaying patient data, diagnostic data, videos and images from computerized diagnostic
instruments or video documentation systems through networks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090439 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090439: FORUM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090439
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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