510(k) · Cleared
ClearedOrims Digital Angiography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midwest Ophthalmic Instruments, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Aug 25, 1995 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 26 later devices descend from it.
- Decided
- Aug 25, 1995
- Review
- 87 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 2 citing it directly.
- This deviceK952480 Orims Digital Angiography SystemMidwest Ophthalmic Instruments, Inc. · 1995
- 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 · 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
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K971685Imagescape Digital Retinal Image SystemTomey Corporation USA · 1997 · cites it directly25descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952480 | Orims Digital Angiography System | Midwest Ophthalmic Instruments, Inc. | 1995 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (26)
See all 262 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?
- 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/K952480 · printed Nov 5, 2026
Cite this page
510(k) Report. “K952480: Orims Digital Angiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952480
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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