510(k) · Cleared
ClearedDigital Retinal Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Inc. -Medical Equipment Group · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Mar 19, 2013 as substantially equivalent to K111612 (Canon, Inc., 2011) after a 158-day review. Its family tree reaches back 7 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 19, 2013
- Review
- 158 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K941234 (1995). 11 ancestors in all, the oldest K946058 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 6 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 5 generations backK031629 Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc. · 2003
- 4 generations backK080883 CR-1Canon, Inc. · 2008
- 3 generations backK090466 Digital Retinal Camera, CR-1 Mark IICanon, Inc. · 2009
- 2 generations backK102013 Digital Retinal CameraCanon Inc. -Medical Equipment Group · 2010
- 1 generation backK111612 Digital Retinal CameraCanon, Inc. · 2011
- This deviceK123208 Digital Retinal CameraCanon Inc. -Medical Equipment Group · 2013
- Descendant · cites it directly · 0 of its ownK201273 ImageSPECTRUMCanon, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK201122 Canon non-mydriatic retinal camera CR seriesCanon, Inc. · 2020
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 |
|---|---|---|---|---|---|
| −7 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −6 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −5 | K031629 | Canon Non-Mydriatic Retinal Camera, Model CR-Dgi | Canon USA, Inc. | 2003 | — |
| −4 | K080883 | CR-1 | Canon, Inc. | 2008 | — |
| −3 | K090466 | Digital Retinal Camera, CR-1 Mark II | Canon, Inc. | 2009 | — |
| −2 | K102013 | Digital Retinal Camera | Canon Inc. -Medical Equipment Group | 2010 | — |
| −1 | K111612 | Digital Retinal Camera | Canon, Inc. | 2011 | — |
| 0 (this device) | K123208 | Digital Retinal Camera | Canon Inc. -Medical Equipment Group | 2013 | — |
| +1 | K201273 | ImageSPECTRUM | Canon, Inc. | 2020 | — |
| +1 | K201122 | Canon non-mydriatic retinal camera CR series | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 HKI? 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 HKI device
- #1 K253176 TearViewscore 12.7 · 5 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 |
|---|---|---|---|
| * | K111612 | Digital Retinal CameraSummary page 1…ommon Name: Ophthalmic camera Classification Name: Ophthalmic camera. (21 CFR 886.1120, Product code HKI) Regulation Class 11 Predicate Device: KI 111612 Canon Digital Retinal Camera CR-2 Plus Device Description: The Digital Retinal Camera CR-2 Plus AF is used for taking digital… | 2011 |
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K201273 (Canon, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HKI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKI
167in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKI
1in 2023
MAUDE reports naming product code HKI, 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 | 2 | — | 0 | 3 |
| 2008 | 5 | 29 | 0 | 1 |
| 2009 | 11 | 104 | 0 | 1 |
| 2010 | 6 | 140 | 0 | 0 |
| 2011 | 7 | 160 | 0 | 0 |
| 2012 | 5 | 179 | 1 | 2 |
| 2013 | 7 | 141 | 0 | 22 |
| 2014 | 4 | 135 | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 4 | 146 | 1 | 66 |
| 2017 | 2 | — | 1 | 20 |
| 2018 | 6 | 71 | 1 | 14 |
| 2019 | 4 | 73 | 0 | 0 |
| 2020 | 5 | 182 | 0 | 5 |
| 2021 | 4 | 155 | 0 | 3 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 5 | 259 | 0 | 1 |
| 2024 | 3 | 28 | 0 | 0 |
| 2025 | 4 | 167 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Digital Retinal Camera CR-2 Plus AF is intended to be used for taking digital images of the retina of the human eye without a mydriatic. The CR-2 Plus AF has the following photography modes: color, red free, cobalt digital and fundus autofluorescence (FAF).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123208: Digital Retinal Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123208
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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