510(k) · Cleared
ClearedOptronics Epic Color Television Camera System (S97340)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Imaging, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Oct 22, 1996 after a 60-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Oct 22, 1996
- Review
- 60 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK963333 Optronics Epic Color Television Camera System (S97340)Karl Storz Imaging, Inc. · 1996
- Descendant · cites it directly · 13 of its ownK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
- Descendant · 2 generations on · 8 of its ownK141068 Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014
- Descendant · 2 generations on · 6 of its ownK123464 Callisto EyeCarl Zeiss Meditec, AG · 2013
- Descendant · 3 generations on · 5 of its ownK141844 Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014
- Descendant · 3 generations on · 4 of its ownK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K101861Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010 · cites it directly13descendants
- K141068Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014 · 2 generations on8descendants
- K123464Callisto EyeCarl Zeiss Meditec, AG · 2013 · 2 generations on6descendants
- K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014 · 3 generations on5descendants
- K143275IOLMaster700Carl Zeiss Meditec, Inc. · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963333 | Optronics Epic Color Television Camera System (S97340) | Karl Storz Imaging, Inc. | 1996 | — |
| +1 | K101861 | Truevision 3D Visualization and Guidance System | Truevision Systems, Incorporated | 2010 | — |
| +2 | K141068 | Zeiss Cataract Suite Markerless | Carl Zeiss Meditec, AG | 2014 | — |
| +2 | K123464 | Callisto Eye | Carl Zeiss Meditec, AG | 2013 | — |
| +3 | K141844 | Rescan 700, Callisto Eye | Carl Zeiss Meditec, AG | 2014 | — |
| +3 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | — | Haag-Streit 900 BQ Slit Lamp Named without a submission number | |
| * | — | Haag-Streit 500 BM Slit Lamp Named without a submission number |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101861 | Truevision 3D Visualization and Guidance System | 2010 | 13 |
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, K101861 (Truevision Systems, Incorporated, 2010) has gone furthest, with 13 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 Optronics EPIC System is intended for use as an accessory to a slit lamp biomicroscope, providing enhanced imaging of the eye for opthalmic examination, diagnosis, treatment definition and clarification, and patient education/proof of treatment need.
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/K963333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963333: Optronics Epic Color Television Camera System (S97340).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963333
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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