510(k) · Cleared
ClearedP200DTx
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 Jan 16, 2015 as substantially equivalent to K134039 (Optos Plc., 2014) and 1 other predicate after a 105-day review. Its family tree reaches back 5 generations to 1987. 5 later devices descend from it.
- Decided
- Jan 16, 2015
- Review
- 105 days
- Class
- Class II
- Product code
- MYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K871268 (1987). 10 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK871268 Rodenstock Scanning Laser OphthalmoscopeG. Rodenstock Instrumente GmbH · 1987
- 4 generations backK983999 PANORAMIC200 OpthalmoscopeOptos Plc. · 1999
- 3 generations backK042001 Panoramic 200AOptos Plc. · 2004
- 2 generations backK060424 Panoramic, Model 200MAOptos Plc. · 2006
- 1 generation backK102492 P200MAAFOptos Plc. · 2010
- This deviceK142897 P200DTxOptos Plc. · 2015
- Descendant · cites it directly · 3 of its ownK173707 P200TEOptos Plc. · 2018
- Descendant · 2 generations on · 1 of its ownK231673 P200TE (A10700)Optos Plc. · 2023
- Descendant · 3 generations on · 0 of its ownK233602 P200TE (A10700)Optos Plc. · 2024
- Descendant · cites it directly · 0 of its ownK221320 Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image…Nidek Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK190732 P200TxEOptos Plc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K173707P200TEOptos Plc. · 2018 · cites it directly3descendants
- K231673P200TE (A10700)Optos Plc. · 2023 · 2 generations on1descendant
- K233602P200TE (A10700)Optos Plc. · 2024 · 3 generations on0descendants
- K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd. · 2023 · cites it directly0descendants
- K190732P200TxEOptos Plc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871268 | Rodenstock Scanning Laser Ophthalmoscope | G. Rodenstock Instrumente GmbH | 1987 | — |
| −4 | K983999 | PANORAMIC200 Opthalmoscope | Optos Plc. | 1999 | — |
| −3 | K042001 | Panoramic 200A | Optos Plc. | 2004 | — |
| −2 | K060424 | Panoramic, Model 200MA | Optos Plc. | 2006 | — |
| −1 | K102492 | P200MAAF | Optos Plc. | 2010 | — |
| 0 (this device) | K142897 | P200DTx | Optos Plc. | 2015 | — |
| +1 | K173707 | P200TE | Optos Plc. | 2018 | — |
| +2 | K231673 | P200TE (A10700) | Optos Plc. | 2023 | — |
| +3 | K233602 | P200TE (A10700) | Optos Plc. | 2024 | — |
| +1 | K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing… | Nidek Co., Ltd. | 2023 | — |
| +1 | K190732 | P200TxE | Optos Plc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K134039 | Daytona Icg (P200TICG)Summary page 7…yout relating to the ability to capture an image. Substantial Equivalence The P200DTx device is as safe and effective as the predicate devices, the Optos Daytona ICG (K134039) and the P200MAAF(K102492) The P200DTx has the same intended use and indications for use and similar principles of operation and… | 2014 |
| * | K102492 | P200MAAFSummary page 7…ty to capture an image. Substantial Equivalence The P200DTx device is as safe and effective as the predicate devices, the Optos Daytona ICG (K134039) and the P200MAAF(K102492) The P200DTx has the same intended use and indications for use and similar principles of operation and technological characteris… | 2010 |
What descends from it? (5)
3 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 28 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K173707 (Optos Plc., 2018) has gone furthest, with 3 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. 2015, 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 P200DTx scanning laser ophthalmoscope is indicated for use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.It is also indicated for use as a widefield scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using Indocyanine Green dye and for aiding in both 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/K142897 · printed Nov 4, 2026
Cite this page
510(k) Report. “K142897: P200DTx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K142897
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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