510(k) · Cleared

Cleared

Digital Fundus Camera, Model CF-60DSI

K041546510(k) TraditionalCleared Jun 23, 200414-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, Inc. · HKI Camera, Ophthalmic, Ac-Powered

Cleared on Jun 23, 2004 as substantially equivalent to K946058 (Canon USA, Inc., 1995) after a 14-day review. Its family tree reaches back 1 generation to 1995. 80 later devices descend from it.

Decided: Jun 23, 2004
Review: 14 days
Class: Class II
Product code: HKI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K946058 (1995). 80 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK946058 60 Fundus Camera CF-60UVCanon USA, Inc. · 1995
This deviceK041546 Digital Fundus Camera, Model CF-60DSICanon, Inc. · 2004
Descendant · cites it directly · 63 of its ownK062295 Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006
Descendant · 2 generations on · 41 of its ownK101223 Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct…Heidelberg Engineering · 2010
Descendant · 3 generations on · 24 of its ownK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
Descendant · 2 generations on · 22 of its ownK092374 Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems · 2009
Descendant · 3 generations on · 21 of its ownK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010

Showing 5 of 80 descendants. See all descendants

Descendants cleared per year

2006high 10 (2018) · low 1 (2006)2026

Most influential descendants

Showing 5 of 80 · See all

K062295Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006 · cites it directly63descendants
K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering · 2010 · 2 generations on41descendants
K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc. · 2012 · 3 generations on24descendants
K092374Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems · 2009 · 2 generations on22descendants
K101935Centervue Digital Retinography SystemCentervue S.P.A. · 2010 · 3 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K946058	60 Fundus Camera CF-60UV	Canon USA, Inc.	1995	—
0 (this device)	K041546	Digital Fundus Camera, Model CF-60DSI	Canon, Inc.	2004	—
+1	K062295	Iri Integrated Retinal Imager	Medivision Medical Imaging, Ltd.	2006	—
+2	K101223	Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra…	Heidelberg Engineering	2010	—
+3	K111157	CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and…	Carl Zeiss Meditec, Inc.	2012	—
+2	K092374	Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan	Ophthalmic Imaging Systems	2009	—
+3	K101935	Centervue Digital Retinography System	Centervue S.P.A.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	1	0
2009	2	0
2010	4	0
2011	2	0
2012	4	0
2013	4	0
2014	5	0
2015	3	0
2016	2	0
2017	3	0
2018	10	0
2019	5	0
2020	6	0
2021	4	0
2022	1	0
2023	6	0
2024	7	0
2025	6	0
2026	3	0

FIG. 1 — Lineage of K041546, 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
*	K946058	60 Fundus Camera CF-60UV Summary page 1 …Trade Name: Canon Model Name: CF-60UVi Classification Name: 86HK1, Ophthalmic cameras FDA 5 10(k) #:K946058 Intended Use: CF-6ODSi is intended to be used for taking digital images pictures of retina…	Canon USA, Inc.	1995	—

Also cleared against K946058: 1 other device →

What descends from it? (80)

See all 80

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

Number	Device	Applicant	Decided	Descendants
K062295	Iri Integrated Retinal Imager	Medivision Medical Imaging, Ltd.	2006	63
K063717	CF-1	Canon, Inc.	2007	18

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?

Its one ancestor has no recall.
Of its descendants, K062295 (Medivision Medical Imaging, Ltd., 2006) has gone furthest, with 63 descendants of its own.
1 other device also cites its predicate K946058.

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?

DIGITAL FUNDUS CAMERA CF-60DSi is intended to be used for taking digital images of retina of human eye with a mydriatic.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041546 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041546: Digital Fundus Camera, Model CF-60DSI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041546

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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