510(k) · Cleared
ClearedEIDON
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centervue S.P.A. · MYC Ophthalmoscope, Laser, Scanning
Cleared on Nov 12, 2014 as substantially equivalent to K111988 (I-Optics BV, 2011) and 1 other predicate after a 107-day review. Its family tree reaches back 7 generations to 1995. 8 later devices descend from it.
- Decided
- Nov 12, 2014
- Review
- 107 days
- Class
- Class II
- Product code
- MYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K941234 (1995). 20 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 deviceK142047 EIDONCentervue S.P.A. · 2014
- Descendant · cites it directly · 2 of its ownK180526 Eidon FACentervue S.P.A. · 2018
- Descendant · 2 generations on · 1 of its ownK211328 Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A. · 2021
- Descendant · cites it directly · 1 of its ownK192113 DRSplusCentervue S.P.A. · 2019
- Descendant · cites it directly · 1 of its ownK150320 CompassCentervue S.P.A. · 2015
- Descendant · 3 generations on · 0 of its ownK241931 OcuMet Beacon (OCUB100)Ocusciences, Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K180526Eidon FACentervue S.P.A. · 2018 · cites it directly2descendants
- K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A. · 2021 · 2 generations on1descendant
- K192113DRSplusCentervue S.P.A. · 2019 · cites it directly1descendant
- K150320CompassCentervue S.P.A. · 2015 · cites it directly1descendant
- K241931OcuMet Beacon (OCUB100)Ocusciences, Inc. · 2025 · 3 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) | K142047 | EIDON | Centervue S.P.A. | 2014 | — |
| +1 | K180526 | Eidon FA | Centervue S.P.A. | 2018 | — |
| +2 | K211328 | Eidon FA, Eidon, Eidon AF, Eidon Uwfl | Centervue S.P.A. | 2021 | — |
| +1 | K192113 | DRSplus | Centervue S.P.A. | 2019 | — |
| +1 | K150320 | Compass | Centervue S.P.A. | 2015 | — |
| +3 | K241931 | OcuMet Beacon (OCUB100) | Ocusciences, Inc. | 2025 | — |
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 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 2 | 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 MYC? 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 MYC device
- #1 K261255 Kowa FM-600score 12.3 · 2 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 |
|---|---|---|---|
| * | K111988 | Easyscan Model 1.2Summary page 6…te Device 1:..............................EasyScan 510(k) Sponsor: ...................................i Optics B.V. 510(k) Number: ...................................K111988 Clearance Date: ...................................28 October 2011 FDA Product Code: ..............................MYC Clas… | 2011 |
| * | K101935 | Centervue Digital Retinography SystemSummary page 6…..............Digital Retinography system (DRS) 510(k) Sponsor: ...................................CenterVue S.p.A. 510(k) Number: ...................................K101935 Clearance Date: ...................................27 October 2010 FDA Product Code: ..............................HKI Clas… | 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 19 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K180526 (Centervue S.P.A., 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MYC devicesMYC Ophthalmoscope, Laser, Scanning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MYC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYC
116in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYC
No recall names MYC since 2007.
Adverse event reports per year · MYC
2in 2023
MAUDE reports naming product code MYC, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 116 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CenterVue EIDON 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/K142047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142047: EIDON.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142047
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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