510(k) · Cleared
ClearedOphthalmic Software Platform RX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Inc. -Medical Equipment Group · NFJ System, Image Management, Ophthalmic
Cleared on Feb 23, 2018 as substantially equivalent to K132438 (Topcon Medical Systems, Inc., 2013) after an 84-day review. Its family tree reaches back 1 generation to 2013. 2 later devices descend from it.
- Decided
- Feb 23, 2018
- Review
- 84 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132438 (2013). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK132438 Imagenet 5 PC Software SystemTopcon Medical Systems, Inc. · 2013
- This deviceK173689 Ophthalmic Software Platform RXCanon Inc. -Medical Equipment Group · 2018
- Descendant · cites it directly · 0 of its ownK201273 ImageSPECTRUMCanon, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK190056 KOWA VK-2sKowa Co. Ltd. Chofu · 2019 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K132438 | Imagenet 5 PC Software System | Topcon Medical Systems, Inc. | 2013 | — |
| 0 (this device) | K173689 | Ophthalmic Software Platform RX | Canon Inc. -Medical Equipment Group | 2018 | — |
| +1 | K201273 | ImageSPECTRUM | Canon, Inc. | 2020 | — |
| +1 | K190056 | KOWA VK-2s | Kowa Co. Ltd. Chofu | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K132438 | Imagenet 5 PC Software SystemSummary page 4…lation: 21 CFR 892.2050 e. Predicate Devices The Ophthalmic Software Platform RX is substantially equivalent to the Topcon IMAGEnet 5 PC Software System (K132438). f. Device Description The Ophthalmic Software Platform RX is an ophthalmic software system indicated for… | 2013 |
What descends from it? (2)
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?
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Ophthalmic Software Platform RX is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display of patient, diagnostic, image data from Canon's mydriatic and non-mydriatic retinal cameras.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173689: Ophthalmic Software Platform RX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173689
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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