510(k) · Cleared
ClearedIcam Fundus Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optovue, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jan 11, 2013 as substantially equivalent to K101935 (Centervue S.P.A., 2010) after a 141-day review. Its family tree reaches back 7 generations to 1995. 8 later devices descend from it.
- Decided
- Jan 11, 2013
- Review
- 141 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K941234 (1995). 19 ancestors in all, the oldest K810880 (1981). 8 later devices descend from it, 4 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 backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 4 generations backK023719 MP-1 Micro PerimeterNidek Technologies Srl · 2002
- 3 generations backK061768 MP-1 MicroperimeterNidek Technologies Srl · 2006
- 2 generations backK070231 ORIONNidek Technologies Srl · 2007
- 1 generation backK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010
- This deviceK122572 Icam Fundus CameraOptovue, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK182199 NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation · 2019
- Descendant · cites it directly · 1 of its ownK222166 SOLIXOptovue, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK251848 Pentacam® Cornea OCTOculus Optikgeräte GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK242508 Verily Numetric Retinal CameraVerily Life Sciences, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK230627 Zilia Ocular FC (ZIL-10002)Zilia, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K182199NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation · 2019 · cites it directly3descendants
- K222166SOLIXOptovue, Inc. · 2022 · cites it directly1descendant
- K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH · 2026 · 2 generations on0descendants
- K242508Verily Numetric Retinal CameraVerily Life Sciences, LLC · 2024 · 2 generations on0descendants
- K230627Zilia Ocular FC (ZIL-10002)Zilia, Inc. · 2023 · 2 generations on0descendants
View 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 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −4 | K023719 | MP-1 Micro Perimeter | Nidek Technologies Srl | 2002 | — |
| −3 | K061768 | MP-1 Microperimeter | Nidek Technologies Srl | 2006 | — |
| −2 | K070231 | ORION | Nidek Technologies Srl | 2007 | — |
| −1 | K101935 | Centervue Digital Retinography System | Centervue S.P.A. | 2010 | — |
| 0 (this device) | K122572 | Icam Fundus Camera | Optovue, Inc. | 2013 | — |
| +1 | K182199 | NFC-700 non-mydriatic auto fundus camera | Crystalvue Medical Corporation | 2019 | — |
| +1 | K222166 | SOLIX | Optovue, Inc. | 2022 | — |
| +2 | K251848 | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | 2026 | — |
| +2 | K242508 | Verily Numetric Retinal Camera | Verily Life Sciences, LLC | 2024 | — |
| +2 | K230627 | Zilia Ocular FC (ZIL-10002) | Zilia, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K101935 | Centervue Digital Retinography SystemSummary page 1…wered and Accessories (21 CFR§ 886.1120) Predicate Devices (1).Digital Retinography System (DRS) (K 10 1935)-manufactured by Centervue, SPA. Intended Use The iCam takes digital images of the posterior and external struc… | 2010 |
What descends from it? (8)
4 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 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K182199 (Crystalvue Medical Corporation, 2019) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K101935.
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 iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions.
iCam is indicated for in-vivo viewing of the posterior and external area of the eye and the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.
iCamn provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122572: Icam Fundus Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122572
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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