510(k) · Cleared
ClearedOptos Advance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optos Plc. · NFJ System, Image Management, Ophthalmic
Cleared on May 25, 2012 as substantially equivalent to K090439 (Carl Zeiss Meditec, Inc., 2009) after a 161-day review. Its family tree reaches back 6 generations to 1990. 4 later devices descend from it.
- Decided
- May 25, 2012
- Review
- 161 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K896095 (1990). 9 ancestors in all. 4 later devices descend from it, 2 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 backK090439 FORUMCarl Zeiss Meditec, Inc. · 2009
- This deviceK113696 Optos AdvanceOptos Plc. · 2012
- Descendant · cites it directly · 2 of its ownK162039 OptosAdvance 4.0 SoftwareOptos Plc. · 2017
- Descendant · 2 generations on · 1 of its ownK211715 RetinAI DiscoveryRetinai Medical AG · 2022
- Descendant · 3 generations on · 0 of its ownK232088 Altris IMSAltris, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK141922 Iris Intelligent Retinal Imaging SystemIntelligent Retinal Imaging Systems, LLC · 2015
Most influential descendants
Showing 4 of 4 · See all- K162039OptosAdvance 4.0 SoftwareOptos Plc. · 2017 · cites it directly2descendants
- K211715RetinAI DiscoveryRetinai Medical AG · 2022 · 2 generations on1descendant
- K232088Altris IMSAltris, Inc. · 2023 · 3 generations on0descendants
- K141922Iris Intelligent Retinal Imaging SystemIntelligent Retinal Imaging Systems, LLC · 2015 · cites it directly0descendants
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 | K090439 | FORUM | Carl Zeiss Meditec, Inc. | 2009 | — |
| 0 (this device) | K113696 | Optos Advance | Optos Plc. | 2012 | — |
| +1 | K162039 | OptosAdvance 4.0 Software | Optos Plc. | 2017 | — |
| +2 | K211715 | RetinAI Discovery | Retinai Medical AG | 2022 | — |
| +3 | K232088 | Altris IMS | Altris, Inc. | 2023 | — |
| +1 | K141922 | Iris Intelligent Retinal Imaging System | Intelligent Retinal Imaging Systems, LLC | 2015 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K090439 | FORUMSummary page 1…0) Product Code: NFJ Device: System, Image Management, Ophthalmic Device Predicate Device: Carl Zeiss Surgical GmbH FORUM Software (K090439) Indications for use The Optos Advance Software is a web-based software system application intended for use in storing, managin… | 2009 |
What descends from it? (4)
2 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 22 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K162039 (Optos Plc., 2017) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K090439.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Optos Advance Software is a web-based 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113696: Optos Advance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113696
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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