510(k) · Cleared
ClearedEasyscan Model 1.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Optics BV · MYC Ophthalmoscope, Laser, Scanning
Cleared on Oct 28, 2011 after a 107-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Oct 28, 2011
- Review
- 107 days
- Class
- Class II
- Product code
- MYC
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK111988 Easyscan Model 1.2I-Optics BV · 2011
- Descendant · cites it directly · 8 of its ownK142047 EIDONCentervue S.P.A. · 2014
- Descendant · 2 generations on · 2 of its ownK180526 Eidon FACentervue S.P.A. · 2018
- Descendant · 3 generations on · 1 of its ownK211328 Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A. · 2021
- Descendant · 2 generations on · 1 of its ownK192113 DRSplusCentervue S.P.A. · 2019
- Descendant · 2 generations on · 1 of its ownK150320 CompassCentervue S.P.A. · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K142047EIDONCentervue S.P.A. · 2014 · cites it directly8descendants
- K180526Eidon FACentervue S.P.A. · 2018 · 2 generations on2descendants
- K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A. · 2021 · 3 generations on1descendant
- K192113DRSplusCentervue S.P.A. · 2019 · 2 generations on1descendant
- K150320CompassCentervue S.P.A. · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111988 | Easyscan Model 1.2 | I-Optics BV | 2011 | — |
| +1 | K142047 | EIDON | Centervue S.P.A. | 2014 | — |
| +2 | K180526 | Eidon FA | Centervue S.P.A. | 2018 | — |
| +3 | K211328 | Eidon FA, Eidon, Eidon AF, Eidon Uwfl | Centervue S.P.A. | 2021 | — |
| +2 | K192113 | DRSplus | Centervue S.P.A. | 2019 | — |
| +2 | K150320 | Compass | Centervue S.P.A. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142047 | EIDON | 2014 | 8 |
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?
- Of its descendants, K142047 (Centervue S.P.A., 2014) has gone furthest, with 8 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. 2011, 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 | — |
https://510kreport.com/device/K111988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111988: Easyscan Model 1.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111988
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026