510(k) · Cleared
ClearedOis Eyescan Portable Modular Imaging System, Model Ois Eyescan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophthalmic Imaging Systems · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Nov 17, 2009 as substantially equivalent to K041367 (Topcon Corp., 2004) and 4 other predicates after a 104-day review. Its family tree reaches back 5 generations to 1995. 22 later devices descend from it.
- Decided
- Nov 17, 2009
- Review
- 104 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K941234 (1995). 13 ancestors in all, the oldest K913929 (1991). 22 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 4 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 3 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 2 generations backK041367 Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004
- 1 generation backK062295 Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006
- This deviceK092374 Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems · 2009
- Descendant · cites it directly · 21 of its ownK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010
- Descendant · 2 generations on · 8 of its ownK142047 EIDONCentervue S.P.A. · 2014
- Descendant · 2 generations on · 8 of its ownK122572 Icam Fundus CameraOptovue, Inc. · 2013
- Descendant · 3 generations on · 3 of its ownK182199 NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation · 2019
- Descendant · 3 generations on · 2 of its ownK180526 Eidon FACentervue S.P.A. · 2018
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K101935Centervue Digital Retinography SystemCentervue S.P.A. · 2010 · cites it directly21descendants
- K142047EIDONCentervue S.P.A. · 2014 · 2 generations on8descendants
- K122572Icam Fundus CameraOptovue, Inc. · 2013 · 2 generations on8descendants
- K182199NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation · 2019 · 3 generations on3descendants
- K180526Eidon FACentervue S.P.A. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −4 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −3 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −2 | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera | Topcon Corp. | 2004 | — |
| −1 | K062295 | Iri Integrated Retinal Imager | Medivision Medical Imaging, Ltd. | 2006 | — |
| 0 (this device) | K092374 | Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan | Ophthalmic Imaging Systems | 2009 | — |
| +1 | K101935 | Centervue Digital Retinography System | Centervue S.P.A. | 2010 | — |
| +2 | K142047 | EIDON | Centervue S.P.A. | 2014 | — |
| +2 | K122572 | Icam Fundus Camera | Optovue, Inc. | 2013 | — |
| +3 | K182199 | NFC-700 non-mydriatic auto fundus camera | Crystalvue Medical Corporation | 2019 | — |
| +3 | K180526 | Eidon FA | Centervue S.P.A. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 12.8 · 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? (5)
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 3…Page 5-2 K092374 Ophthalmic Inaging Systems 510(k) Topcon TRC-50EX and TRC-501X (K041367), manfaLcturcd by TOPCON Corp. Topcon TRC devices are ophthalmic camera systems intended to photograph the ey… | 2004 |
| * | K913929 | DFC-1024 & DFC-512 Digital Imaging SystemSummary page 3…t clearance as an addition or a modification to the 510(k) clearance of the TRC-NW200 device, K041367. WinStation Digital Imaging System (K9 13929) manufactured by Ophthalmic Imaging Systems is used in conjunction with ophthalmic fundus cameras to take ima… | 1991 |
| * | K062295 | Iri Integrated Retinal ImagerSummary page 3…s of the eye, similar to the O1S EyeScan device using the Retina Module or Fluorescein Angiography Module. IRI Integrated Retinal Imager (K062295) manufactured by Medivision Medical Imaging is intended to photograph the eye's findus similar to the 0IS Eye… | 2006 |
| * | K982057 | BC 900 Slit LampSummary page 3…best of our understanding, the BX900 received market clearance as an addition or a modification to the 510(k) clearance of the BC900 device K982057. Page 5-3 K092374… | 1998 |
| * | K973064 | Keeler Tearscope-PlusSummary page 4…74 Ophthalmic Imaging Systems 510(k) Tearscope Plus (K973064) manufactured by Keeler is a device for specular observation of the tear film, similar to the OIS… | 1998 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101935 | Centervue Digital Retinography System | 2010 | 21 |
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 14 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K101935 (Centervue S.P.A., 2010) has gone furthest, with 21 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. 2009, 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 OIS EyeScan Portable Modular Imaging System is a portable monocular camera intended for imaging of both the posterior segment (including structures of the retina, vitreous and choroid) and anterior segment (including structures of the orbit, lids, cornea, iris and lens) of the eye. The device is suitable for documentation of findings in a clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092374 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092374: Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092374
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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