510(k) · Cleared
ClearedCentervue Digital Retinography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centervue S.P.A. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Oct 27, 2010 as substantially equivalent to K092374 (Ophthalmic Imaging Systems, 2009) and 1 other predicate after a 107-day review. Its family tree reaches back 6 generations to 1995. 21 later devices descend from it.
- Decided
- Oct 27, 2010
- Review
- 107 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K941234 (1995). 18 ancestors in all, the oldest K810880 (1981). 21 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 5 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 4 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 3 generations backK023719 MP-1 Micro PerimeterNidek Technologies Srl · 2002
- 2 generations backK061768 MP-1 MicroperimeterNidek Technologies Srl · 2006
- 1 generation backK070231 ORIONNidek Technologies Srl · 2007
- This deviceK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010
- Descendant · cites it directly · 8 of its ownK142047 EIDONCentervue S.P.A. · 2014
- Descendant · cites it directly · 8 of its ownK122572 Icam Fundus CameraOptovue, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK182199 NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation · 2019
- Descendant · 2 generations on · 2 of its ownK180526 Eidon FACentervue S.P.A. · 2018
- Descendant · cites it directly · 2 of its ownK180306 NexyNext Sight Srl · 2018
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K142047EIDONCentervue S.P.A. · 2014 · cites it directly8descendants
- K122572Icam Fundus CameraOptovue, Inc. · 2013 · cites it directly8descendants
- K182199NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation · 2019 · 2 generations on3descendants
- K180526Eidon FACentervue S.P.A. · 2018 · 2 generations on2descendants
- K180306NexyNext Sight Srl · 2018 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −5 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −4 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −3 | K023719 | MP-1 Micro Perimeter | Nidek Technologies Srl | 2002 | — |
| −2 | K061768 | MP-1 Microperimeter | Nidek Technologies Srl | 2006 | — |
| −1 | K070231 | ORION | Nidek Technologies Srl | 2007 | — |
| 0 (this device) | K101935 | Centervue Digital Retinography System | Centervue S.P.A. | 2010 | — |
| +1 | K142047 | EIDON | Centervue S.P.A. | 2014 | — |
| +1 | K122572 | Icam Fundus Camera | Optovue, Inc. | 2013 | — |
| +2 | K182199 | NFC-700 non-mydriatic auto fundus camera | Crystalvue Medical Corporation | 2019 | — |
| +2 | K180526 | Eidon FA | Centervue S.P.A. | 2018 | — |
| +1 | K180306 | Nexy | Next Sight Srl | 2018 | — |
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 | 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? (2)
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 |
|---|---|---|---|
| * | K092374 | Ois Eyescan Portable Modular Imaging System, Model Ois EyescanSummary page 2…510(k) Holder 510(k) No. Date cleared EyeScan Ophthalmic Imaging Systems K092374 17 November 2009 Orion Nidlek Technologies SrI K070231… | 2009 |
| * | K070231 | ORIONSummary page 2…Ophthalmic Imaging Systems K092374 17 November 2009 Orion Nidlek Technologies SrI K070231 24 April 2007 TEST DATA The ORS has undergone extensive performance testing before release to… | 2007 |
What descends from it? (21)
See all 215 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 15 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K142047 (Centervue S.P.A., 2014) has gone furthest, with 8 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. 2010, 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 CenterVue Digital Retinography System ORS is intended for taking digital images of a human retina without the use of a mydriatic agent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101935 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101935: Centervue Digital Retinography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101935
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