510(k) · Cleared
ClearedOptos Limited Panoramic 200CAF
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 Jul 15, 2010 as substantially equivalent to K983999 (Optos Plc., 1999) after a 132-day review. Its family tree reaches back 2 generations to 1987. 9 later devices descend from it.
- Decided
- Jul 15, 2010
- Review
- 132 days
- Class
- Class II
- Product code
- MYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871268 (1987). 4 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK871268 Rodenstock Scanning Laser OphthalmoscopeG. Rodenstock Instrumente GmbH · 1987
- 1 generation backK983999 PANORAMIC200 OpthalmoscopeOptos Plc. · 1999
- This deviceK100644 Optos Limited Panoramic 200CAFOptos Plc. · 2010
- 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 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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 |
|---|---|---|---|---|---|
| −2 | K871268 | Rodenstock Scanning Laser Ophthalmoscope | G. Rodenstock Instrumente GmbH | 1987 | — |
| −1 | K983999 | PANORAMIC200 Opthalmoscope | Optos Plc. | 1999 | — |
| 0 (this device) | K100644 | Optos Limited Panoramic 200CAF | Optos Plc. | 2010 | — |
| +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 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K983999 | PANORAMIC200 OpthalmoscopeSummary page 1…83 843333 Contact Person: Robert Tweedlie Ph.D. Date Prepared June 14, 2010 Predicate Device Optos Limited's Panoramic 200 (K983999) Indications for Use The Panoramic 200CAF scanning laser ophthalmoscope is intended to be used as a wide field and retinal auto… | 1999 |
What descends from it? (9)
2 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 23 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K102492 (Optos Plc., 2010) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K983999.
How does its category compare?
All MYC devicesMYC Ophthalmoscope, Laser, Scanning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Panoramic 200CAF scanning laser ophthalmoscope is intended to be used as a wide field and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100644: Optos Limited Panoramic 200CAF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100644
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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