510(k) · Cleared
ClearedIri Integrated Retinal Imager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivision Medical Imaging, Ltd. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Oct 20, 2006 as substantially equivalent to K041367 (Topcon Corp., 2004) and 2 other predicates after a 74-day review. Its family tree reaches back 4 generations to 1995. 63 later devices descend from it.
- Decided
- Oct 20, 2006
- Review
- 74 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K941234 (1995). 9 ancestors in all, the oldest K946058 (1995). 63 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 3 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 2 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 1 generation backK041367 Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004
- This deviceK062295 Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006
- Descendant · cites it directly · 41 of its ownK101223 Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct…Heidelberg Engineering · 2010
- Descendant · 2 generations on · 24 of its ownK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
- Descendant · cites it directly · 22 of its ownK092374 Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems · 2009
- Descendant · 2 generations on · 21 of its ownK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010
- Descendant · cites it directly · 15 of its ownK121993 Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis…Heidelberg Engineering GmbH · 2012
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering · 2010 · cites it directly41descendants
- K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc. · 2012 · 2 generations on24descendants
- K092374Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems · 2009 · cites it directly22descendants
- K101935Centervue Digital Retinography SystemCentervue S.P.A. · 2010 · 2 generations on21descendants
- K121993Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis…Heidelberg Engineering GmbH · 2012 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −3 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −2 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −1 | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera | Topcon Corp. | 2004 | — |
| 0 (this device) | K062295 | Iri Integrated Retinal Imager | Medivision Medical Imaging, Ltd. | 2006 | — |
| +1 | K101223 | Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra… | Heidelberg Engineering | 2010 | — |
| +2 | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and… | Carl Zeiss Meditec, Inc. | 2012 | — |
| +1 | K092374 | Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan | Ophthalmic Imaging Systems | 2009 | — |
| +2 | K101935 | Centervue Digital Retinography System | Centervue S.P.A. | 2010 | — |
| +1 | K121993 | Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct… | Heidelberg Engineering GmbH | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 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 12.8 · 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? (3)
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 |
|---|---|---|---|
| * | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraSummary page 2…al Imager device is substantially equivalent to a combination of the following predicate devices: -TRC-NW200 (K041367) manufactured by Topcon. TRC- NW200 is a monocular ophthalmic non-mydriatic camera syst… | 2004 |
| * | K021787 | VisucamSummary page 2…processing of the captured images, similar to the IRITM Integrated Retinal Imager device. - VisuCam Lite (K021787) manufactured by Carl Zeiss. VisuCam Lite is an Ophthalmic Camera system, which is intended to… | 2002 |
| * | K041546 | Digital Fundus Camera, Model CF-60DSISummary page 2…photograph the fundus, similar to the IRITM Integrated Retinal Imager device. - Canon CF-60DSi (k041546), manufactured by Canon Inc. The CF-60DSi is a digital fundus camera used for taking digital… | 2004 |
What descends from it? (63)
See all 633 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101223 | Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FA | 2010 | 41 |
| K092374 | Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan | 2009 | 22 |
| K121993 | Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis… | 2012 | 15 |
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 11 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K101223 (Heidelberg Engineering, 2010) has gone furthest, with 41 descendants of its own.
- 4 other devices also cite its predicate K041367.
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?
The IRI Integrated Retinal Imager System is a monocular retinal imager designed for routine use. The imager is suitable for documentation of findings in a clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062295 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062295: Iri Integrated Retinal Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062295
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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