510(k) · Cleared
ClearedZeta Diagnostic Retinal Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeta Development Laboratories · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jul 26, 2002 as substantially equivalent to K982689 (Ophthalmic Imaging Systems, 1998) and 3 other predicates after a 23-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Jul 26, 2002
- Review
- 23 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K913929 (1991). 6 ancestors in all, the oldest K870039 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK913929 DFC-1024 & DFC-512 Digital Imaging SystemOphthalmic Imaging Systems · 1991 · Recalled
- 2 generations backK971685 Imagescape Digital Retinal Image SystemTomey Corporation USA · 1997
- 1 generation backK980295 Ophthavision Imaging SystemMrp Group, Inc. · 1998
- This deviceK022164 Zeta Diagnostic Retinal Imaging SystemZeta Development Laboratories · 2002
- Descendant · cites it directly · 0 of its ownK093071 Fundus Photo Ophthalmic Digital Imaging System, Model CFD-440Fundus Photo, LLC · 2010
Most influential descendants
Showing 1 of 1 · See all- K093071Fundus Photo Ophthalmic Digital Imaging System, Model CFD-440Fundus Photo, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913929 | DFC-1024 & DFC-512 Digital Imaging System | Ophthalmic Imaging Systems | 1991 | 5 |
| −2 | K971685 | Imagescape Digital Retinal Image System | Tomey Corporation USA | 1997 | — |
| −1 | K980295 | Ophthavision Imaging System | Mrp Group, Inc. | 1998 | — |
| 0 (this device) | K022164 | Zeta Diagnostic Retinal Imaging System | Zeta Development Laboratories | 2002 | — |
| +1 | K093071 | Fundus Photo Ophthalmic Digital Imaging System, Model CFD-440 | Fundus Photo, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 12.7 · 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? (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 |
|---|---|---|---|
| * | K982689 | Winstation Retinal ImagerSummary page 1…icate Devices Trade Name Manufacturer 510 (k) Winstation Retinal Imager Ophthalmic Imaging Systems K982689 Ophthavision Imaging System MRP Group, Inc. K980295 Imagescope Digital Imaging System Tomey… | 1998 |
| * | K980295 | Ophthavision Imaging SystemSummary page 1…510 (k) Winstation Retinal Imager Ophthalmic Imaging Systems K982689 Ophthavision Imaging System MRP Group, Inc. K980295 Imagescope Digital Imaging System Tomey Corporation USA K971685 - .… | 1998 |
| * | K971685 | Imagescape Digital Retinal Image SystemSummary page 1…K982689 Ophthavision Imaging System MRP Group, Inc. K980295 Imagescope Digital Imaging System Tomey Corporation USA K971685 - . . .… | 1997 |
| * | K870039 | Imagenet Digital Ophthalmic Imaging SystemSummary page 1….- Imagenet Digital Ophthalmic Imaging Topcon K870039 Intended Use F -- The Zeta Diag… | 1987 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093071 | Fundus Photo Ophthalmic Digital Imaging System, Model CFD-440 | 2010 | 0 |
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 11 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K093071 (Fundus Photo, LLC, 2010) has gone furthest, with 0 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 | — |
What is it indicated for?
The Zeta Diagnostic Retinal Imaging System is intended to be used to capture,
archive, recall and display black and white, and color images of the retina
captured using an ophthalmic camera during angiography non-invasively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022164: Zeta Diagnostic Retinal 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/K022164
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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