510(k) · Cleared
ClearedImageSPECTRUM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon, Inc. · NFJ System, Image Management, Ophthalmic
Cleared on Sep 25, 2020 as substantially equivalent to K173689 (Canon Inc. -Medical Equipment Group, 2018) and 1 other predicate after a 136-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Sep 25, 2020
- Review
- 136 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K941234 (1995). 14 ancestors in all, the oldest K946058 (1995). No later device cites it as a predicate yet.
- Root · 8 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 7 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 6 generations backK031629 Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc. · 2003
- 5 generations backK080883 CR-1Canon, Inc. · 2008
- 4 generations backK090466 Digital Retinal Camera, CR-1 Mark IICanon, Inc. · 2009
- 3 generations backK102013 Digital Retinal CameraCanon Inc. -Medical Equipment Group · 2010
- 2 generations backK111612 Digital Retinal CameraCanon, Inc. · 2011
- 1 generation backK123208 Digital Retinal CameraCanon Inc. -Medical Equipment Group · 2013
- This deviceK201273 ImageSPECTRUMCanon, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −7 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −6 | K031629 | Canon Non-Mydriatic Retinal Camera, Model CR-Dgi | Canon USA, Inc. | 2003 | — |
| −5 | K080883 | CR-1 | Canon, Inc. | 2008 | — |
| −4 | K090466 | Digital Retinal Camera, CR-1 Mark II | Canon, Inc. | 2009 | — |
| −3 | K102013 | Digital Retinal Camera | Canon Inc. -Medical Equipment Group | 2010 | — |
| −2 | K111612 | Digital Retinal Camera | Canon, Inc. | 2011 | — |
| −1 | K123208 | Digital Retinal Camera | Canon Inc. -Medical Equipment Group | 2013 | — |
| 0 (this device) | K201273 | ImageSPECTRUM | Canon, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K173689 | Ophthalmic Software Platform RXSummary page 4…stems. Classification Name: System, Image Management, Ophthalmic Classification Regulation: 892.2050 Product Code: NFJ Predicate Device Ophthalmic Software Platform RX (K173689) Reference Device CR-2 Plus AF (K123208) Device Description The imageSPECTRUM V6 is an ophthalmic imaging software for acquirin… | 2018 |
| * | K123208 | Digital Retinal CameraSummary page 4…Management, Ophthalmic Classification Regulation: 892.2050 Product Code: NFJ Predicate Device Ophthalmic Software Platform RX (K173689) Reference Device CR-2 Plus AF (K123208) Device Description The imageSPECTRUM V6 is an ophthalmic imaging software for acquiring, storing, managing, processing and disp… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 14 ancestors has a recall.
- 1 other device also cites its predicate K173689.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 imageSPECTRUM V6 is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display patient, diagnostic and image data from Canon digital retinal cameras. It is also indicated for review of patient, diagnostic and image data and measurement by trained healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201273: ImageSPECTRUM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201273
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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