510(k) · Cleared

Cleared

Canon Non-Mydriatic Retinal Camera, Model CR-Dgi

K031629510(k) TraditionalCleared Jun 6, 200310-day reviewClass II21 CFR 886.1120

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Canon USA, Inc. · HKI Camera, Ophthalmic, Ac-Powered

Cleared on Jun 6, 2003 as substantially equivalent to K980246 (Canon USA, Inc., 1998) after a 10-day review. Its family tree reaches back 2 generations to 1995. 92 later devices descend from it.

Decided: Jun 6, 2003
Review: 10 days
Class: Class II
Product code: HKI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K941234 (1995). 92 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
1 generation backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
This deviceK031629 Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc. · 2003
Descendant · cites it directly · 79 of its ownK041367 Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004
Descendant · 2 generations on · 63 of its ownK062295 Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006
Descendant · 3 generations on · 41 of its ownK101223 Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct…Heidelberg Engineering · 2010
Descendant · 2 generations on · 30 of its ownK090115 Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009
Descendant · 2 generations on · 28 of its ownK100207 Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010

Showing 5 of 92 descendants. See all descendants

Descendants cleared per year

2004high 10 (2018) · low 0 (2005)2026

Most influential descendants

Showing 5 of 92 · See all

K041367Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004 · cites it directly79descendants
K062295Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006 · 2 generations on63descendants
K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering · 2010 · 3 generations on41descendants
K090115Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009 · 2 generations on30descendants
K100207Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010 · 2 generations on28descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K941234	Non-Mydriatic Retinal Camera	Canon USA, Inc.	1995	—
−1	K980246	Non-Mydriatic Retinal Camera, Model CR6-45NM	Canon USA, Inc.	1998	—
0 (this device)	K031629	Canon Non-Mydriatic Retinal Camera, Model CR-Dgi	Canon USA, Inc.	2003	—
+1	K041367	Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera	Topcon Corp.	2004	—
+2	K062295	Iri Integrated Retinal Imager	Medivision Medical Imaging, Ltd.	2006	—
+3	K101223	Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra…	Heidelberg Engineering	2010	—
+2	K090115	Retina Camera TRC-NW7SF Mark II	Topcon Corp.	2009	—
+2	K100207	Non-Mydriatic Retinal Camera, Model TRC-NW8F	Topcon Corp.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2008	1	0
2009	3	0
2010	5	0
2011	2	0
2012	4	0
2013	6	0
2014	6	0
2015	3	0
2016	3	0
2017	5	0
2018	10	0
2019	5	0
2020	6	0
2021	4	0
2022	2	0
2023	7	0
2024	9	0
2025	6	0
2026	3	0

FIG. 1 — Lineage of K031629, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K980246	Non-Mydriatic Retinal Camera, Model CR6-45NM Summary page 1 …Trade Name: Canon Model Name: CQg5NM Classification Name: 86HK1, , Ophthalmic cameras FDA 510(k) #: K980246 Description Of Device: CR-DGi is a n improved model of CR5-45NM. Intended Use: CR-DGi is intended to be used for taking…	Canon USA, Inc.	1998	—

Also cleared against K980246: 4 other devices →

What descends from it? (92)

See all 92

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041367	Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera	Topcon Corp.	2004	79
K080883	CR-1	Canon, Inc.	2008	17

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 8 years and passes through 1 company; a new generation was cleared every 5.1 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K041367 (Topcon Corp., 2004) has gone furthest, with 79 descendants of its own.
4 other devices also cite its predicate K980246.

How does its category compare?

All HKI devices

HKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HKI

4in 2025

2007high 11 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HKI

167in 2025

2007high 259 (2023) · low 28 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HKI

1in 2018

2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HKI

1in 2023

2007high 66 (2016) · low 0 (2010)2025

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?

Canon Non-Mydriatic Retinal Camera CR-DGi is intended to be used for taking pictures of retina of human eye without a mydriatic.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031629 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031629: Canon Non-Mydriatic Retinal Camera, Model CR-Dgi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031629

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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