510(k) · Cleared
ClearedNidek Advanced Vision Information System (Navis)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek, Inc. · NFJ System, Image Management, Ophthalmic
Cleared on Nov 19, 2002 as substantially equivalent to K012093 (Aetmed, S.P.A., 2001) after a 377-day review. Its family tree reaches back 4 generations to 1990. 61 later devices descend from it.
- Decided
- Nov 19, 2002
- Review
- 377 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K896095 (1990). 7 ancestors in all. 61 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 3 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 2 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 1 generation backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- This deviceK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- Descendant · cites it directly · 50 of its ownK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- Descendant · cites it directly · 32 of its ownK090439 FORUMCarl Zeiss Meditec, Inc. · 2009
- Descendant · cites it directly · 29 of its ownK093313 SynergyTopcon Medical Systems, Inc. · 2009
- Descendant · 2 generations on · 25 of its ownK122938 Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · Recalled
- Descendant · 2 generations on · 13 of its ownK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K082364Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…Topcon Corp. · 2008 · cites it directly50descendants
- K090439FORUMCarl Zeiss Meditec, Inc. · 2009 · cites it directly32descendants
- K093313SynergyTopcon Medical Systems, Inc. · 2009 · cites it directly29descendants
- K122938Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · 2 generations on25descendants
- K101861Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −3 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −2 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −1 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| 0 (this device) | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| +1 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| +1 | K090439 | FORUM | Carl Zeiss Meditec, Inc. | 2009 | — |
| +1 | K093313 | Synergy | Topcon Medical Systems, Inc. | 2009 | — |
| +2 | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist Match | Carl Zeiss Meditec, AG | 2012 | 1 |
| +2 | K101861 | Truevision 3D Visualization and Guidance System | Truevision Systems, Incorporated | 2010 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2017 | 8 | 0 |
| 2018 | 7 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K012093 | Aetmed Image Processing Software | 2001 |
What descends from it? (61)
See all 617 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or… | 2008 | 50 |
| K090439 | FORUM | 2009 | 32 |
| K093313 | Synergy | 2009 | 29 |
| K110129 | Righton Zoom Slit Lamp Microscope with Photo Option | 2011 | 5 |
| K142423 | EyeSuite Imaging | 2014 | 2 |
| K110006 | Ois Symphony Image Managment System | 2011 | 0 |
| K090266 | Matchedflicker | 2009 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K082364 (Topcon Corp., 2008) has gone furthest, with 50 descendants of its own.
- 1 other device also cites its predicate K012093.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Nidek Advanced Vision Information System (NAVIS) is a software program intended for use in the collection, storage and clinical information management of patient data, diagnostic data and the images from computerized diagnostic instruments through direct connection with the instruments, or through networks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013694 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013694: Nidek Advanced Vision Information System (Navis).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013694
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026