510(k) · Cleared
ClearedJive X Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visus Technology Transfer GmbH · LLZ System, Image Processing, Radiological
Cleared on Feb 16, 2006 after a 94-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Feb 16, 2006
- Review
- 94 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK053183 Jive X SoftwareVisus Technology Transfer GmbH · 2006
- Descendant · cites it directly · 6 of its ownK142750 JiveXVisus Technology Transfer GmbH · 2015
- Descendant · 2 generations on · 4 of its ownK162008 JiveXVisus Technology Transfer GmbH · 2016
- Descendant · 3 generations on · 3 of its ownK181964 JiveXVisus Health IT GmbH · 2018
- Descendant · 4 generations on · 2 of its ownK200703 JiveXVisus Health IT GmbH · 2020
- Descendant · 5 generations on · 1 of its ownK212321 JiveX (Model Number / Release: 5.3)Visus Health IT GmbH · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K142750JiveXVisus Technology Transfer GmbH · 2015 · cites it directly6descendants
- K162008JiveXVisus Technology Transfer GmbH · 2016 · 2 generations on4descendants
- K181964JiveXVisus Health IT GmbH · 2018 · 3 generations on3descendants
- K200703JiveXVisus Health IT GmbH · 2020 · 4 generations on2descendants
- K212321JiveX (Model Number / Release: 5.3)Visus Health IT GmbH · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053183 | Jive X Software | Visus Technology Transfer GmbH | 2006 | — |
| +1 | K142750 | JiveX | Visus Technology Transfer GmbH | 2015 | — |
| +2 | K162008 | JiveX | Visus Technology Transfer GmbH | 2016 | — |
| +3 | K181964 | JiveX | Visus Health IT GmbH | 2018 | — |
| +4 | K200703 | JiveX | Visus Health IT GmbH | 2020 | — |
| +5 | K212321 | JiveX (Model Number / Release: 5.3) | Visus Health IT GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142750 | JiveX | 2015 | 6 |
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, K142750 (Visus Technology Transfer GmbH, 2015) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
To be used with images from a variety of radiological modalities including CT, MRI, ultrasound, nuclear medicine, CR, DR, etc. to store and retrieve images and patient information.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted us;i': :n FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K053183 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053183: Jive X Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053183
Report an extraction error
Are you the manufacturer?
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