510(k) · Cleared
ClearedTruevision 3D Visualization and Guidance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truevision Systems, Incorporated · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Dec 22, 2010 as substantially equivalent to K963333 (Karl Storz Imaging, Inc., 1996) and 2 other predicates after a 173-day review. Its family tree reaches back 6 generations to 1990. 13 later devices descend from it.
- Decided
- Dec 22, 2010
- Review
- 173 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K896095 (1990). 15 ancestors in all, the oldest K870039 (1987). 13 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 4 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 3 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 2 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 1 generation backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- This deviceK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
- Descendant · cites it directly · 8 of its ownK141068 Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014
- Descendant · cites it directly · 6 of its ownK123464 Callisto EyeCarl Zeiss Meditec, AG · 2013
- Descendant · 2 generations on · 5 of its ownK141844 Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014
- Descendant · 2 generations on · 4 of its ownK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K141068Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014 · cites it directly8descendants
- K123464Callisto EyeCarl Zeiss Meditec, AG · 2013 · cites it directly6descendants
- K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014 · 2 generations on5descendants
- K143275IOLMaster700Carl Zeiss Meditec, Inc. · 2015 · 2 generations on4descendants
- K170171IOLMaster 700Carl Zeiss Meditec, AG · 2017 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −5 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −4 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −3 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −2 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −1 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| 0 (this device) | K101861 | Truevision 3D Visualization and Guidance System | Truevision Systems, Incorporated | 2010 | — |
| +1 | K141068 | Zeiss Cataract Suite Markerless | Carl Zeiss Meditec, AG | 2014 | — |
| +1 | K123464 | Callisto Eye | Carl Zeiss Meditec, AG | 2013 | — |
| +2 | K141844 | Rescan 700, Callisto Eye | Carl Zeiss Meditec, AG | 2014 | — |
| +2 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
| +3 | K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K963333 | Optronics Epic Color Television Camera System (S97340)Summary page 2…Surgical Microscope/21 CFR8Y8.4700, EPT 2) Optronics EPIC Color Television Camera System Karl Storz Imaging Ophthalmic camera/21 CFR 886.1850 K963333, HKI 3) OphthaVtsion Imaging System MVRP Group, Inc. Ophthalmic camera/21CFR 886.1850 K980295, HKI 4)… | 1996 |
| * | K980295 | Ophthavision Imaging SystemSummary page 2…g Ophthalmic camera/21 CFR 886.1850 K963333, HKI 3) OphthaVtsion Imaging System MVRP Group, Inc. Ophthalmic camera/21CFR 886.1850 K980295, HKI 4) IMAGEnet Professional PC Software, Digital Image Management Software Topcon Corporation Picture… | 1998 |
| * | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…Summary page 2…Professional PC Software, Digital Image Management Software Topcon Corporation Picture archiving and communications system/21 CFR 892.2050 K(082364, NFJ Description of the Device Subject to Premarket Notification: The TrueVision® 3D Visualization and Guidance System is a ster… | 2008 |
| * | — | TrueVision®- Visualization System for Microsurgery, Class 1 Device Named without a submission number |
What descends from it? (13)
See all 132 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?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K141068 (Carl Zeiss Meditec, AG, 2014) has gone furthest, with 8 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. 2010, this device’s year, is highlighted.
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 TrueVision® 3D Visualization and Guidance System is an adjunct imaging tool that provides onscreen guidance with alignment, orientation, and sizing for eye surgery. The system is intended for use as a preoperative and postoperative image capture tool with visualization and guidance provided during anterior segment ophthalmic surgical procedures, including limbal relaxing incisions, capsulorhexis and toric intraocular lens (toric IOL) positioning. The system utilizes surgeon confirmation at each step for planning and positioning of guidance templates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101861: Truevision 3D Visualization and Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101861
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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