510(k) · Cleared
ClearedPanoramic, Model 200MA
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 Mar 17, 2006 as substantially equivalent to K042001 (Optos Plc., 2004) after a 28-day review. Its family tree reaches back 3 generations to 1987. 8 later devices descend from it.
- Decided
- Mar 17, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- MYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871268 (1987). 6 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK871268 Rodenstock Scanning Laser OphthalmoscopeG. Rodenstock Instrumente GmbH · 1987
- 2 generations backK983999 PANORAMIC200 OpthalmoscopeOptos Plc. · 1999
- 1 generation backK042001 Panoramic 200AOptos Plc. · 2004
- This deviceK060424 Panoramic, Model 200MAOptos Plc. · 2006
- Descendant · cites it directly · 7 of its ownK102492 P200MAAFOptos Plc. · 2010
- Descendant · 2 generations on · 5 of its ownK142897 P200DTxOptos Plc. · 2015
- Descendant · 3 generations on · 3 of its ownK173707 P200TEOptos Plc. · 2018
- Descendant · 4 generations on · 1 of its ownK231673 P200TE (A10700)Optos Plc. · 2023
- Descendant · 5 generations on · 0 of its ownK233602 P200TE (A10700)Optos Plc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K102492P200MAAFOptos Plc. · 2010 · cites it directly7descendants
- K142897P200DTxOptos Plc. · 2015 · 2 generations on5descendants
- K173707P200TEOptos Plc. · 2018 · 3 generations on3descendants
- K231673P200TE (A10700)Optos Plc. · 2023 · 4 generations on1descendant
- K233602P200TE (A10700)Optos Plc. · 2024 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871268 | Rodenstock Scanning Laser Ophthalmoscope | G. Rodenstock Instrumente GmbH | 1987 | — |
| −2 | K983999 | PANORAMIC200 Opthalmoscope | Optos Plc. | 1999 | — |
| −1 | K042001 | Panoramic 200A | Optos Plc. | 2004 | — |
| 0 (this device) | K060424 | Panoramic, Model 200MA | Optos Plc. | 2006 | — |
| +1 | K102492 | P200MAAF | Optos Plc. | 2010 | — |
| +2 | K142897 | P200DTx | Optos Plc. | 2015 | — |
| +3 | K173707 | P200TE | Optos Plc. | 2018 | — |
| +4 | K231673 | P200TE (A10700) | Optos Plc. | 2023 | — |
| +5 | K233602 | P200TE (A10700) | Optos Plc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K042001 | Panoramic 200ASummary page 3…and effectiveness. Thus, the Optos Panoramic 200MA Ophthalmoscope is substantially equivalent to Optos' legally marketed Scanning Laser Ophthalnoscopes (SLO), the P200A (K042001) Page 47 of 145 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2004 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102492 | P200MAAF | 2010 | 7 |
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 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K102492 (Optos Plc., 2010) has gone furthest, with 7 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.
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?
This device is indicated for use as a wide field and retinal fluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest themselves in the retina.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060424 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060424: Panoramic, Model 200MA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060424
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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