510(k) · Cleared
ClearedHeidelberg Retina Angiograph FA/Icga (Hra/C)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heidelberg Engineering · HLI Ophthalmoscope, Ac-Powered
Cleared on Jul 29, 1997 after an 83-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 19 later devices descend from it.
- Decided
- Jul 29, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 4 citing it directly.
- This deviceK971671 Heidelberg Retina Angiograph FA/Icga (Hra/C)Heidelberg Engineering · 1997
- 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 · 3 generations on · 7 of its ownK102492 P200MAAFOptos Plc. · 2010
- Descendant · cites it directly · 6 of its ownK134039 Daytona Icg (P200TICG)Optos Plc. · 2014
- Descendant · 2 generations on · 5 of its ownK142897 P200DTxOptos Plc. · 2015
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K042001Panoramic 200AOptos Plc. · 2004 · cites it directly9descendants
- K060424Panoramic, Model 200MAOptos Plc. · 2006 · 2 generations on8descendants
- K102492P200MAAFOptos Plc. · 2010 · 3 generations on7descendants
- K134039Daytona Icg (P200TICG)Optos Plc. · 2014 · cites it directly6descendants
- K142897P200DTxOptos Plc. · 2015 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971671 | Heidelberg Retina Angiograph FA/Icga (Hra/C) | Heidelberg Engineering | 1997 | — |
| +1 | K042001 | Panoramic 200A | Optos Plc. | 2004 | — |
| +2 | K060424 | Panoramic, Model 200MA | Optos Plc. | 2006 | — |
| +3 | K102492 | P200MAAF | Optos Plc. | 2010 | — |
| +1 | K134039 | Daytona Icg (P200TICG) | Optos Plc. | 2014 | — |
| +2 | K142897 | P200DTx | Optos Plc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (19)
See all 194 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?
- Of its descendants, K042001 (Optos Plc., 2004) 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?
Device is intended for viewing the retinal and/or choroidal circulation patterns that are illuminated using fluorescein or indocyanine green dye, and for aiding in the:
management of age-related macula degeneration (AMD)
detection of choroidal neovascularization (CNV)
assessment of diabetic retinopathy
assessment of diabetic maculopathy
treatment control of diabetic maculopathy, AMD, CNV
detection of retinal vascular disturbances
assessment of choroidal circulation
diagnosis of chorioditis or choroidal diseases
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971671 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971671: Heidelberg Retina Angiograph FA/Icga (Hra/C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971671
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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