510(k) · Cleared
ClearedCallisto Eye
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · NFJ System, Image Management, Ophthalmic
Cleared on Mar 5, 2013 as substantially equivalent to K101861 (Truevision Systems, Incorporated, 2010) after a 116-day review. Its family tree reaches back 7 generations to 1990. 6 later devices descend from it.
- Decided
- Mar 5, 2013
- Review
- 116 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K896095 (1990). 16 ancestors in all, the oldest K870039 (1987). 6 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 5 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 4 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 3 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 2 generations backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- 1 generation backK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
- This deviceK123464 Callisto EyeCarl Zeiss Meditec, AG · 2013
- Descendant · cites it directly · 5 of its ownK141844 Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014
- Descendant · cites it directly · 2 of its ownK180858 CALLISTO eyeCarl Zeiss Meditec, AG · 2018
- Descendant · 2 generations on · 1 of its ownK231676 CALLISTO eyeCarl Zeiss Meditec, AG · 2023
- Descendant · 2 generations on · 1 of its ownK180229 RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG · 2019
- Descendant · 3 generations on · 0 of its ownK233421 Rescan 700Carl Zeiss Meditec, AG · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014 · cites it directly5descendants
- K180858CALLISTO eyeCarl Zeiss Meditec, AG · 2018 · cites it directly2descendants
- K231676CALLISTO eyeCarl Zeiss Meditec, AG · 2023 · 2 generations on1descendant
- K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG · 2019 · 2 generations on1descendant
- K233421Rescan 700Carl Zeiss Meditec, AG · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −6 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −5 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −4 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −3 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −2 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| −1 | K101861 | Truevision 3D Visualization and Guidance System | Truevision Systems, Incorporated | 2010 | — |
| 0 (this device) | K123464 | Callisto Eye | Carl Zeiss Meditec, AG | 2013 | — |
| +1 | K141844 | Rescan 700, Callisto Eye | Carl Zeiss Meditec, AG | 2014 | — |
| +1 | K180858 | CALLISTO eye | Carl Zeiss Meditec, AG | 2018 | — |
| +2 | K231676 | CALLISTO eye | Carl Zeiss Meditec, AG | 2023 | — |
| +2 | K180229 | RESCAN 700, CALLISTO eye | Carl Zeiss Meditec, AG | 2019 | — |
| +3 | K233421 | Rescan 700 | Carl Zeiss Meditec, AG | 2024 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 NFJ? 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 NFJ device
- #1 K260694 Zeiss Clinic 360score 15.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K101861 | Truevision 3D Visualization and Guidance SystemSummary page 3…ntal technological characteristics of CALLISTO eye with software version 3.0 are similar to the predicate device, TrueVision® 3D Visualization and Guidance System (K101861). Both CALLISTO eye and TrueVision 3D Visualization and Guidance System are devices that work in conjunction with a surgical m… | 2010 |
What descends from it? (6)
2 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 23 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K141844 (Carl Zeiss Meditec, AG, 2014) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K101861.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NFJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NFJ
85in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFJ
2in 2022
MAUDE reports naming product code NFJ, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 67 | 0 | 0 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 73 | 0 | 6 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 87 | 1 | 2 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 5 | 175 | 0 | 4 |
| 2018 | 7 | 84 | 0 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 5 | 116 | 2 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 284 | 1 | 2 |
| 2023 | 4 | 85 | 0 | 0 |
| 2024 | 2 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
CALLISTO eye is an assistance system that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The system allows the remote control of the surgical microscope.
The graphical guidance tools, as displayed on the CALLISTO eye Panel PC or microscope eye piece, aid the surgeon to insert, align, position, and register an artificial lens. These tools are intended for anterior segment ophthalmic surgical procedures, including positioning and angular alignment of toric intraocular lenses, limbal relaxing incisions, and capsulorhexis. The system utilizes surgeon information for positioning of graphical guidance tools.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123464: Callisto Eye.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123464
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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