510(k) · Cleared
ClearedPANORAMIC200 Opthalmoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optos Plc. · HLI Ophthalmoscope, Ac-Powered
Cleared on Feb 3, 1999 as substantially equivalent to K981640 (Odyssey Optical Systems, LLC, 1998) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1987. 13 later devices descend from it.
- Decided
- Feb 3, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K871268 (1987). 3 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK871268 Rodenstock Scanning Laser OphthalmoscopeG. Rodenstock Instrumente GmbH · 1987
- This deviceK983999 PANORAMIC200 OpthalmoscopeOptos Plc. · 1999
- Descendant · cites it directly · 9 of its ownK100644 Optos Limited Panoramic 200CAFOptos Plc. · 2010
- Descendant · cites it directly · 9 of its ownK042001 Panoramic 200AOptos Plc. · 2004
- Descendant · 2 generations on · 8 of its ownK060424 Panoramic, Model 200MAOptos Plc. · 2006
- Descendant · 2 generations on · 7 of its ownK102492 P200MAAFOptos Plc. · 2010
- Descendant · 3 generations on · 5 of its ownK142897 P200DTxOptos Plc. · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K100644Optos Limited Panoramic 200CAFOptos Plc. · 2010 · cites it directly9descendants
- K042001Panoramic 200AOptos Plc. · 2004 · cites it directly9descendants
- K060424Panoramic, Model 200MAOptos Plc. · 2006 · 2 generations on8descendants
- K102492P200MAAFOptos Plc. · 2010 · 2 generations on7descendants
- K142897P200DTxOptos Plc. · 2015 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871268 | Rodenstock Scanning Laser Ophthalmoscope | G. Rodenstock Instrumente GmbH | 1987 | — |
| 0 (this device) | K983999 | PANORAMIC200 Opthalmoscope | Optos Plc. | 1999 | — |
| +1 | K100644 | Optos Limited Panoramic 200CAF | Optos Plc. | 2010 | — |
| +1 | K042001 | Panoramic 200A | Optos Plc. | 2004 | — |
| +2 | K060424 | Panoramic, Model 200MA | Optos Plc. | 2006 | — |
| +2 | K102492 | P200MAAF | Optos Plc. | 2010 | — |
| +3 | K142897 | P200DTx | Optos Plc. | 2015 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 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 HLI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K983137 | Unnamed device Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…ingdom 011 44 1383 628714 011 44 1383 628706 Mr. Philip Rickett 1 November 1998 Scanning Laser Ophthalmoscope (SLO) Scanning Laser Ophthalmoscope (SLO) Intended Uses K983137_ Manufacturer Odyssey Optical Systems Rodenstock Rodenstock 510(k) K981640 K882517 K871268 Optos plc’s (“Optos”) Panoramic2… | |
| * | K981640 | S2LOSummary page 1…8 Scanning Laser Ophthalmoscope (SLO) Scanning Laser Ophthalmoscope (SLO) Intended Uses K983137_ Manufacturer Odyssey Optical Systems Rodenstock Rodenstock 510(k) K981640 K882517 K871268 Optos plc’s (“Optos”) Panoramic200 and Odyssey Optical System’s S’LO (“the Odyssey .. S’L0O”) and G. Rodenstoc… | 1998 |
| * | K882517 | Rodenstock Scanning Laser OphthalmoscopeSummary page 1…ng Laser Ophthalmoscope (SLO) Scanning Laser Ophthalmoscope (SLO) Intended Uses K983137_ Manufacturer Odyssey Optical Systems Rodenstock Rodenstock 510(k) K981640 K882517 K871268 Optos plc’s (“Optos”) Panoramic200 and Odyssey Optical System’s S’LO (“the Odyssey .. S’L0O”) and G. Rodenstock Instrum… | 1989 |
| * | K871268 | Rodenstock Scanning Laser OphthalmoscopeSummary page 1…Ophthalmoscope (SLO) Scanning Laser Ophthalmoscope (SLO) Intended Uses K983137_ Manufacturer Odyssey Optical Systems Rodenstock Rodenstock 510(k) K981640 K882517 K871268 Optos plc’s (“Optos”) Panoramic200 and Odyssey Optical System’s S’LO (“the Odyssey .. S’L0O”) and G. Rodenstock Instruments Gmb… | 1987 |
What descends from it? (13)
See all 133 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K100644 (Optos Plc., 2010) has gone furthest, with 9 descendants of its own.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HLI
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HLI
112in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HLI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HLI
2in 2024
MAUDE reports naming product code HLI, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 36 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 4 | 112 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 2 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is indicated for use as a wide field ophthalmoscope for diagnosing and monitoring diseases or disorders that manifest themselves in the posterior pole of the eye.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983999: PANORAMIC200 Opthalmoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983999
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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