510(k) · Cleared
ClearedRetinal Functional Imager (Rfi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optical Imaging, Ltd. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Nov 17, 2006 as substantially equivalent to K954780 (Kowa Optimed, Inc., 1995) and 3 other predicates after a 92-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Nov 17, 2006
- Review
- 92 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K943955 (1994). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK943955 Retina FlowmeterHeidelberg Engineering · 1994
- 1 generation backK992606 Canon Laser Blood Flowmeter (CLBF) Model 100Canon USA, Inc. · 2000
- This deviceK062416 Retinal Functional Imager (Rfi)Optical Imaging, Ltd. · 2006
- Descendant · cites it directly · 1 of its ownK080180 Modification to Retinal Function Imager (Rfi)Optical Imaging, Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK193319 XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging SystemVasoptic Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK153239 LSFG-NaviSoftcare Co., Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See all- K080180Modification to Retinal Function Imager (Rfi)Optical Imaging, Ltd. · 2008 · cites it directly1descendant
- K193319XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging SystemVasoptic Medical, Inc. · 2020 · 2 generations on0descendants
- K153239LSFG-NaviSoftcare Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943955 | Retina Flowmeter | Heidelberg Engineering | 1994 | — |
| −1 | K992606 | Canon Laser Blood Flowmeter (CLBF) Model 100 | Canon USA, Inc. | 2000 | — |
| 0 (this device) | K062416 | Retinal Functional Imager (Rfi) | Optical Imaging, Ltd. | 2006 | — |
| +1 | K080180 | Modification to Retinal Function Imager (Rfi) | Optical Imaging, Ltd. | 2008 | — |
| +2 | K193319 | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System | Vasoptic Medical, Inc. | 2020 | — |
| +1 | K153239 | LSFG-Navi | Softcare Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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 HKI? 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 HKI device
- #1 K253176 TearViewscore 12.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954780 | Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500CSummary page 2…The Retinal Functional Imager (RFI) is considered to be substantially equivalent to its predicate devices: * Kowa Fundus Camera FX-500 - cleared under K954780; * Zeiss FF450 VISUPAC -cleared under K011877; * Canon - Ophthalmoscope Laser Blood Flow Meter - LBFM Model 100… | 1995 |
| * | K011877 | FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus…Summary page 2…red to be substantially equivalent to its predicate devices: * Kowa Fundus Camera FX-500 - cleared under K954780; * Zeiss FF450 VISUPAC -cleared under K011877; * Canon - Ophthalmoscope Laser Blood Flow Meter - LBFM Model 100 - cleared under K992606; and * Heidelberg O… | 2001 |
| * | K992606 | Canon Laser Blood Flowmeter (CLBF) Model 100Summary page 2…cleared under K954780; * Zeiss FF450 VISUPAC -cleared under K011877; * Canon - Ophthalmoscope Laser Blood Flow Meter - LBFM Model 100 - cleared under K992606; and * Heidelberg Ophthalmoscope Retina Flow Meter - cleared under K943955 without raising new safety and/or… | 2000 |
| * | K943955 | Retina FlowmeterSummary page 2…- Ophthalmoscope Laser Blood Flow Meter - LBFM Model 100 - cleared under K992606; and * Heidelberg Ophthalmoscope Retina Flow Meter - cleared under K943955 without raising new safety and/or effectiveness issues. All these devices are ophthalmic imaging management systems… | 1994 |
What descends from it? (3)
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 12 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K080180 (Optical Imaging, Ltd., 2008) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K954780.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HKI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKI
167in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKI
1in 2023
MAUDE reports naming product code HKI, 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 | 2 | — | 0 | 3 |
| 2008 | 5 | 29 | 0 | 1 |
| 2009 | 11 | 104 | 0 | 1 |
| 2010 | 6 | 140 | 0 | 0 |
| 2011 | 7 | 160 | 0 | 0 |
| 2012 | 5 | 179 | 1 | 2 |
| 2013 | 7 | 141 | 0 | 22 |
| 2014 | 4 | 135 | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 4 | 146 | 1 | 66 |
| 2017 | 2 | — | 1 | 20 |
| 2018 | 6 | 71 | 1 | 14 |
| 2019 | 4 | 73 | 0 | 0 |
| 2020 | 5 | 182 | 0 | 5 |
| 2021 | 4 | 155 | 0 | 3 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 5 | 259 | 0 | 1 |
| 2024 | 3 | 28 | 0 | 0 |
| 2025 | 4 | 167 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Retinal Functional Imager (RFI) is intended to observe, capture, display, and store images of patients' fundus (retina) under mydriatic conditions with the information of blood flow (velocity) and path of flow in a retinal vessel, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062416 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062416: Retinal Functional Imager (Rfi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062416
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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