510(k) · Cleared
ClearedDaytona Icg (P200TICG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optos Plc. · MYC Ophthalmoscope, Laser, Scanning
Cleared on Apr 11, 2014 as substantially equivalent to K971671 (Heidelberg Engineering, 1997) after a 101-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.
- Decided
- Apr 11, 2014
- Review
- 101 days
- Class
- Class II
- Product code
- MYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971671 (1997). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK971671 Heidelberg Retina Angiograph FA/Icga (Hra/C)Heidelberg Engineering · 1997
- This deviceK134039 Daytona Icg (P200TICG)Optos Plc. · 2014
- Descendant · cites it directly · 5 of its ownK142897 P200DTxOptos Plc. · 2015
- Descendant · 2 generations on · 3 of its ownK173707 P200TEOptos Plc. · 2018
- Descendant · 3 generations on · 1 of its ownK231673 P200TE (A10700)Optos Plc. · 2023
- Descendant · 4 generations on · 0 of its ownK233602 P200TE (A10700)Optos Plc. · 2024
- Descendant · 2 generations on · 0 of its ownK221320 Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image…Nidek Co., Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K142897P200DTxOptos Plc. · 2015 · cites it directly5descendants
- K173707P200TEOptos Plc. · 2018 · 2 generations on3descendants
- K231673P200TE (A10700)Optos Plc. · 2023 · 3 generations on1descendant
- K233602P200TE (A10700)Optos Plc. · 2024 · 4 generations on0descendants
- K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971671 | Heidelberg Retina Angiograph FA/Icga (Hra/C) | Heidelberg Engineering | 1997 | — |
| 0 (this device) | K134039 | Daytona Icg (P200TICG) | Optos Plc. | 2014 | — |
| +1 | K142897 | P200DTx | Optos Plc. | 2015 | — |
| +2 | K173707 | P200TE | Optos Plc. | 2018 | — |
| +3 | K231673 | P200TE (A10700) | Optos Plc. | 2023 | — |
| +4 | K233602 | P200TE (A10700) | Optos Plc. | 2024 | — |
| +2 | K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing… | Nidek Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | K971671 | Heidelberg Retina Angiograph FA/Icga (Hra/C)Summary page 1…Contact Person: Robert Tweedlie Ph.D. Date Prepared: April 10, 2014 Predicate Device: Heidelberg Retina Angiography 2 (K971671) Indications for Use The Daytona lOG scanning laser ophthalmoscope is indicated for use as a wide field scanning laser ophthalmos… | 1997 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142897 | P200DTx | 2015 | 5 |
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?
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 Daytona lOG scanning laser ophthalmoscape is indicated for use as a wide field scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using indlocyanine green dye and for aiding in born the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K134039: Daytona Icg (P200TICG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K134039
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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