510(k) · Cleared
ClearedSynergy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Medical Systems, Inc. · NFJ System, Image Management, Ophthalmic
Cleared on Dec 2, 2009 as substantially equivalent to K082364 (Topcon Corp., 2008) and 3 other predicates after a 41-day review. Its family tree reaches back 6 generations to 1990. 29 later devices descend from it.
- Decided
- Dec 2, 2009
- Review
- 41 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K896095 (1990). 13 ancestors in all, the oldest K870039 (1987). 29 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 4 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 3 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 2 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 1 generation backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- This deviceK093313 SynergyTopcon Medical Systems, 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 · cites it directly · 9 of its ownK132667 Synergy OdmTopcon Medical Systems, Inc. · 2013
- Descendant · 2 generations on · 8 of its ownK151952 Synergy ODMTopcon Medical Systems, Inc. · 2015
- Descendant · 3 generations on · 4 of its ownK182376 HarmonyTopcon Medical Systems, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK150467 Retina WorkplaceCarl Zeiss Meditec, AG · 2015
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K122938Forum Forum Archive Forum Archive & Viewer Forum Assist MatchCarl Zeiss Meditec, AG · 2012 · cites it directly25descendants
- K132667Synergy OdmTopcon Medical Systems, Inc. · 2013 · cites it directly9descendants
- K151952Synergy ODMTopcon Medical Systems, Inc. · 2015 · 2 generations on8descendants
- K182376HarmonyTopcon Medical Systems, Inc. · 2018 · 3 generations on4descendants
- K150467Retina WorkplaceCarl Zeiss Meditec, AG · 2015 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −5 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −4 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −3 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −2 | 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 | — |
| 0 (this device) | K093313 | Synergy | Topcon Medical Systems, Inc. | 2009 | — |
| +1 | K122938 | Forum Forum Archive Forum Archive & Viewer Forum Assist Match | Carl Zeiss Meditec, AG | 2012 | 1 |
| +1 | K132667 | Synergy Odm | Topcon Medical Systems, Inc. | 2013 | — |
| +2 | K151952 | Synergy ODM | Topcon Medical Systems, Inc. | 2015 | — |
| +3 | K182376 | Harmony | Topcon Medical Systems, Inc. | 2018 | — |
| +2 | K150467 | Retina Workplace | Carl Zeiss Meditec, AG | 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 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2020 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…Summary page 2…sual Name System, image management, ophthalmic Classification Name 21 C.F.R. 892.2050 Predicate Devices Topcon Corporation IMAGEnet Professional PC Software System (K082364) Nidek Advanced Vision Information System (NAVIS) (K013694) Digital Healthcare, Ltd. Oculab IP (K071299) Topcon Corporation 3D OC… | 2008 |
| * | K013694 | Nidek Advanced Vision Information System (Navis)Summary page 2…tion Name 21 C.F.R. 892.2050 Predicate Devices Topcon Corporation IMAGEnet Professional PC Software System (K082364) Nidek Advanced Vision Information System (NAVIS) (K013694) Digital Healthcare, Ltd. Oculab IP (K071299) Topcon Corporation 3D OCT-100O (K072971) Intended Use / Indications for Use Syner… | 2002 |
| * | K071299 | IP System, Oculab IP, Optomize IP, Retasure IPSummary page 2…ces Topcon Corporation IMAGEnet Professional PC Software System (K082364) Nidek Advanced Vision Information System (NAVIS) (K013694) Digital Healthcare, Ltd. Oculab IP (K071299) Topcon Corporation 3D OCT-100O (K072971) Intended Use / Indications for Use Synergy is a comprehensive software platform inten… | 2007 |
| * | K072971 | Topcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of Retinal…Summary page 2…onal PC Software System (K082364) Nidek Advanced Vision Information System (NAVIS) (K013694) Digital Healthcare, Ltd. Oculab IP (K071299) Topcon Corporation 3D OCT-100O (K072971) Intended Use / Indications for Use Synergy is a comprehensive software platform intended for use in acquisition or importing,… | 2009 |
What descends from it? (29)
See all 294 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 6 companies; a new generation was cleared every 2.9 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K122938 (Carl Zeiss Meditec, AG, 2012) has gone furthest, with 25 descendants of its own.
- 5 other devices also cite its predicate K082364.
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?
Synergy is a comprehensive software platform intended for use in acquisition or
importing, processing, measurement, analysis and storage of clinical images and
videos of the eye as well as in management of patient data, diagnostic data, clinical
information, reports from ophthalmic diagnostic instruments through either a direct
connection with the instruments or through computerized networks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093313 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093313: Synergy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093313
Report an extraction error
Are you the manufacturer?
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