510(k) · Cleared
ClearedImagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Corp. · NFJ System, Image Management, Ophthalmic
Cleared on Sep 30, 2008 as substantially equivalent to K870039 (Par Microsystems Corp., 1987) and 1 other predicate after a 43-day review. Its family tree reaches back 5 generations to 1990. 50 later devices descend from it.
- Decided
- Sep 30, 2008
- Review
- 43 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K896095 (1990). 9 ancestors in all, the oldest K870039 (1987). 50 later devices descend from it, 6 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 deviceK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- 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 · cites it directly · 13 of its ownK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
- 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
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- 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 · cites it directly13descendants
- K132667Synergy OdmTopcon Medical Systems, Inc. · 2013 · 2 generations on9descendants
- K151952Synergy ODMTopcon Medical Systems, Inc. · 2015 · 3 generations on8descendants
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) | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| +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 |
| +1 | K101861 | Truevision 3D Visualization and Guidance System | Truevision Systems, Incorporated | 2010 | — |
| +2 | K132667 | Synergy Odm | Topcon Medical Systems, Inc. | 2013 | — |
| +3 | K151952 | Synergy ODM | Topcon Medical Systems, Inc. | 2015 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K870039 | Imagenet Digital Ophthalmic Imaging SystemSummary page 1…e System is substantially equivalent to the IMAGEnet Digital Ophthalmic Imiaging System (v.2.12; IMAGEnet 2000) marketed by Topcon, 5 10(k) Premarket Notification Number K87003 9, FDA Product Code DSF. Secondly, it is substantially equivalent to the Nidek Advanced Vision Informat'ion… | 1987 |
| * | K013694 | Nidek Advanced Vision Information System (Navis)Summary page 2…on System Product Code NFJ, and Inc., 510(k) Premarket Notification Number: K013694, FDA system) in basic design… | 2002 |
What descends from it? (50)
See all 506 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 18 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K093313 (Topcon Medical Systems, Inc., 2009) has gone furthest, with 29 descendants of its own.
- 4 other devices also cite its predicate K870039.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 IMAGEnet Professional PC Software 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 computerized diagnostic imaging devices through direct connection with the instruments or through computerized networks.
The software system is indicated for use with retinal camera or digital camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slit lamps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082364: Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082364
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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