510(k) · Cleared
ClearedImagescape Digital Retinal Image System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomey Corporation USA · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jun 24, 1997 as substantially equivalent to K913929 (Ophthalmic Imaging Systems, 1991) and 1 other predicate after a 48-day review. Its family tree reaches back 1 generation to 1991. 25 later devices descend from it.
- Decided
- Jun 24, 1997
- Review
- 48 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913929 (1991). 2 ancestors in all. 25 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK913929 DFC-1024 & DFC-512 Digital Imaging SystemOphthalmic Imaging Systems · 1991 · Recalled
- This deviceK971685 Imagescape Digital Retinal Image SystemTomey Corporation USA · 1997
- Descendant · cites it directly · 23 of its ownK980295 Ophthavision Imaging SystemMrp Group, Inc. · 1998
- Descendant · 2 generations on · 13 of its ownK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
- Descendant · 3 generations on · 8 of its ownK141068 Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014
- Descendant · 3 generations on · 6 of its ownK123464 Callisto EyeCarl Zeiss Meditec, AG · 2013
- Descendant · 2 generations on · 6 of its ownK091935 Lipiview Ocular Surface InterferometerTearscience, Inc. · 2009
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K980295Ophthavision Imaging SystemMrp Group, Inc. · 1998 · cites it directly23descendants
- K101861Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010 · 2 generations on13descendants
- K141068Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014 · 3 generations on8descendants
- K123464Callisto EyeCarl Zeiss Meditec, AG · 2013 · 3 generations on6descendants
- K091935Lipiview Ocular Surface InterferometerTearscience, Inc. · 2009 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913929 | DFC-1024 & DFC-512 Digital Imaging System | Ophthalmic Imaging Systems | 1991 | 5 |
| 0 (this device) | K971685 | Imagescape Digital Retinal Image System | Tomey Corporation USA | 1997 | — |
| +1 | K980295 | Ophthavision Imaging System | Mrp Group, Inc. | 1998 | — |
| +2 | K101861 | Truevision 3D Visualization and Guidance System | Truevision Systems, Incorporated | 2010 | — |
| +3 | K141068 | Zeiss Cataract Suite Markerless | Carl Zeiss Meditec, AG | 2014 | — |
| +3 | K123464 | Callisto Eye | Carl Zeiss Meditec, AG | 2013 | — |
| +2 | K091935 | Lipiview Ocular Surface Interferometer | Tearscience, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K913929 | DFC-1024 & DFC-512 Digital Imaging SystemSummary page 1…hthalmic camera with digital imaging system. Classification Name AC-powered ophthalmic camera Predicate Devices Ophthalmic Imaging Systems -- DFC Digital Imaging System (K913929) Midwest Ophthalmic Instruments -- ORIMS Digital Angiography (952480) Topcon -- Imagenet Digital Imaging System Intended Use The… | 1991 |
| * | K952480 | Orims Digital Angiography SystemSummary page 1…wered ophthalmic camera Predicate Devices Ophthalmic Imaging Systems -- DFC Digital Imaging System (K913929) Midwest Ophthalmic Instruments -- ORIMS Digital Angiography (952480) Topcon -- Imagenet Digital Imaging System Intended Use The ImageScape is intended to be used to capture, store and manipulate d… | 1995 |
| * | — | Imagenet Digital Imaging System Named without a submission number |
What descends from it? (25)
See all 253 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?
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 ImageScape is intended to capture, store, and manipulate digital images of the retina taken by a fundus camera.
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/K971685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971685: Imagescape Digital Retinal Image System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971685
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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