510(k) · Cleared
ClearedKinepict Medical Imaging Tool version v2.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinepict Health, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Mar 5, 2020 as substantially equivalent to K153346 (Siemens Medical Solutions USA, Inc., 2016) after a 324-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- Mar 5, 2020
- Review
- 324 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010938 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 4 generations backK040970 LeonardoSiemens Medical Systems, Inc. · 2004 · Recalled
- 3 generations backK042995 X-LeonardoSiemens Medical Solutions USA, Inc. · 2004
- 2 generations backK143319 Syngo X-workplace SW VD10Siemens Medi Cal Solutions, Inc. · 2015 · Recalled
- 1 generation backK153346 syngo Application Software VD11Siemens Medical Solutions USA, Inc. · 2016
- This deviceK190993 Kinepict Medical Imaging Tool version v2.2Kinepict Health, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK202056 Kinepict Medical Imaging Tool 4.0Kinepict Health, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K202056Kinepict Medical Imaging Tool 4.0Kinepict Health, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010938 | Syngo Multimodality Workstation | Siemens Medical Solutions USA, Inc. | 2001 | 5 |
| −4 | K040970 | Leonardo | Siemens Medical Systems, Inc. | 2004 | 1 |
| −3 | K042995 | X-Leonardo | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −2 | K143319 | Syngo X-workplace SW VD10 | Siemens Medi Cal Solutions, Inc. | 2015 | 2 |
| −1 | K153346 | syngo Application Software VD11 | Siemens Medical Solutions USA, Inc. | 2016 | — |
| 0 (this device) | K190993 | Kinepict Medical Imaging Tool version v2.2 | Kinepict Health, Ltd. | 2020 | — |
| +1 | K202056 | Kinepict Medical Imaging Tool 4.0 | Kinepict Health, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K153346 | syngo Application Software VD11Summary page 5…LLZ Legally Marketed Predicate Device Trade Name: Syngo Application Software VD11 510(k) Clearance K153346 Clearance Date February 24, 2015 Classification Name:… | 2016 |
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 |
|---|---|---|---|
| K202056 | Kinepict Medical Imaging Tool 4.0 | 2021 | 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 19 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K202056 (Kinepict Health, Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K153346.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
Kinepict Medical Imaging Tool version v2.2 is intended to be used to visualize blood vessel structures by detecting the movement of the contrast medium bolus in standard-of-care angiography examination. This software is intended to be used in addition to, or as replacement for current DSA imaging. Kinepict Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and reporting workstation. It can also be…
Read the full statement (143 words)
Kinepict Medical Imaging Tool version v2.2 is intended to be used to visualize blood vessel structures by detecting the
movement of the contrast medium bolus in standard-of-care angiography examination. This software is intended to be
used in addition to, or as replacement for current DSA imaging.
Kinepict Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing,
and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore,
Kinepict Software can be deployed on systems of several angiography system family. It provides image guided solutions
in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in
interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional
radiology, and interventional neuroradiology.
Kinepict Software can also be combined with fluoroscopy systems or Radiographic systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190993: Kinepict Medical Imaging Tool version v2.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190993
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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