510(k) · Cleared
ClearedNon-Mydriatic Retinal Camera, Model CR6-45NM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon USA, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on May 6, 1998 as substantially equivalent to K941234 (Canon USA, Inc., 1995) after a 103-day review. Its family tree reaches back 1 generation to 1995. 120 later devices descend from it.
- Decided
- May 6, 1998
- Review
- 103 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941234 (1995). 120 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- This deviceK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- Descendant · cites it directly · 96 of its ownK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- Descendant · cites it directly · 92 of its ownK031629 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
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 120 · See all- K014274Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002 · cites it directly96descendants
- K031629Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc. · 2003 · cites it directly92descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| 0 (this device) | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| +1 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 10 | 0 |
| 2019 | 9 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 8 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K941234 | Non-Mydriatic Retinal CameraSummary page 1…-45NM 86HKI, Non-Mydriatic Retinal Camera, AC Powered Document Control N umber. Canon CR5-46NM 86HKI, Non-Mydriatic Retinal Camera, AC Powered Document Control Number. K941234 CR6-45NM is an improved model of CR6-46NM. CR6-45NM has employed Auto Flash Adjustment and Advanced Internal Fixation Lamp, maki… | 1995 |
What descends from it? (120)
See all 1205 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?
- Its one ancestor has no recall.
- Of its descendants, K014274 (Nidek, Inc., 2002) has gone furthest, with 96 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.
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?
Taking pictures of retina of human eye.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980246: Non-Mydriatic Retinal Camera, Model CR6-45NM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980246
Report an extraction error
Are you the manufacturer?
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