510(k) · Cleared
Recalled · Class II · 2016DFC-1024 & DFC-512 Digital Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophthalmic Imaging Systems · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Nov 27, 1991 after an 85-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 53 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 27, 1991
- Review
- 85 days
- Class
- Class II
- Product code
- HKI
- Recalls
- 5
- Predicates
- 0
53 later devices descend from it, 4 citing it directly.
- This deviceK913929 DFC-1024 & DFC-512 Digital Imaging SystemOphthalmic Imaging Systems · 1991
- Descendant · cites it directly · 25 of its ownK971685 Imagescape Digital Retinal Image SystemTomey Corporation USA · 1997
- Descendant · cites it directly · 23 of its ownK980295 Ophthavision Imaging SystemMrp Group, Inc. · 1998
- Descendant · cites it directly · 22 of its ownK092374 Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems · 2009
- Descendant · 2 generations on · 21 of its ownK101935 Centervue Digital Retinography SystemCentervue S.P.A. · 2010
- Descendant · 2 generations on · 13 of its ownK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K971685Imagescape Digital Retinal Image SystemTomey Corporation USA · 1997 · cites it directly25descendants
- K980295Ophthavision Imaging SystemMrp Group, Inc. · 1998 · cites it directly23descendants
- K092374Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems · 2009 · cites it directly22descendants
- K101935Centervue Digital Retinography SystemCentervue S.P.A. · 2010 · 2 generations on21descendants
- K101861Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913929 | DFC-1024 & DFC-512 Digital Imaging System | Ophthalmic Imaging Systems | 1991 | — |
| +1 | K971685 | Imagescape Digital Retinal Image System | Tomey Corporation USA | 1997 | — |
| +1 | K980295 | Ophthavision Imaging System | Mrp Group, Inc. | 1998 | — |
| +1 | K092374 | Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan | Ophthalmic Imaging Systems | 2009 | — |
| +2 | K101935 | Centervue Digital Retinography System | Centervue S.P.A. | 2010 | — |
| +2 | K101861 | Truevision 3D Visualization and Guidance System | Truevision Systems, Incorporated | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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 12.7 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (53)
See all 534 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 9, 2016 | Class II | Z-1017-2017 | Software design | This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user. |
| Dec 9, 2016 | Class II | Z-1142-2017 | Software design | Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to reduce the risk to patient health. |
| Apr 4, 2016 | Class II | Z-1681-2017 | Software Design Change | The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions. |
| Apr 4, 2016 | Class II | Z-1828-2017 | Software in the Use Environment | During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently. |
| Mar 28, 2016 | Class II | Z-1246-2017 | Device Design | Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K971685 (Tomey Corporation USA, 1997) has gone furthest, with 25 descendants of its own.
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 | — |
https://510kreport.com/device/K913929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913929: DFC-1024 & DFC-512 Digital Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913929
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026