510(k) · Cleared
ClearedJiveX
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 Sep 16, 2016 as substantially equivalent to K142750 (Visus Technology Transfer GmbH, 2015) after a 58-day review. Its family tree reaches back 10 generations to 1997. 4 later devices descend from it.
- Decided
- Sep 16, 2016
- Review
- 58 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K971684 (1997). 28 ancestors in all, the oldest K945188 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations between
- 3 generations backK101666 Syngo. Plaza VA20ASiemens AG Medical Solutions · 2010 · Recalled
- 2 generations backK132532 Syngo.Plaza VB10ASiemens AG Healthcare · 2013 · Recalled
- 1 generation backK142750 JiveXVisus Technology Transfer GmbH · 2015
- This deviceK162008 JiveXVisus Technology Transfer GmbH · 2016
- Descendant · cites it directly · 3 of its ownK181964 JiveXVisus Health IT GmbH · 2018
- Descendant · 2 generations on · 2 of its ownK200703 JiveXVisus Health IT GmbH · 2020
- Descendant · 3 generations on · 1 of its ownK212321 JiveX (Model Number / Release: 5.3)Visus Health IT GmbH · 2021
- Descendant · 4 generations on · 0 of its ownK231041 JiveX (Model Number / Release: 5.4)Visus Health IT GmbH · 2023
Show all 10 generations
- Root · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 9 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 8 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 6 generations backK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- 5 generations backK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- 4 generations backK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- 3 generations backK101666 Syngo. Plaza VA20ASiemens AG Medical Solutions · 2010 · Recalled
- 2 generations backK132532 Syngo.Plaza VB10ASiemens AG Healthcare · 2013 · Recalled
- 1 generation backK142750 JiveXVisus Technology Transfer GmbH · 2015
- This deviceK162008 JiveXVisus Technology Transfer GmbH · 2016
Most influential descendants
Showing 4 of 4 · See all- K181964JiveXVisus Health IT GmbH · 2018 · cites it directly3descendants
- K200703JiveXVisus Health IT GmbH · 2020 · 2 generations on2descendants
- K212321JiveX (Model Number / Release: 5.3)Visus Health IT GmbH · 2021 · 3 generations on1descendant
- K231041JiveX (Model Number / Release: 5.4)Visus Health IT GmbH · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −9 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −8 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −7 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −6 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| −5 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| −4 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| −3 | K101666 | Syngo. Plaza VA20A | Siemens AG Medical Solutions | 2010 | 3 |
| −2 | K132532 | Syngo.Plaza VB10A | Siemens AG Healthcare | 2013 | 11 |
| −1 | K142750 | JiveX | Visus Technology Transfer GmbH | 2015 | — |
| 0 (this device) | K162008 | JiveX | Visus Technology Transfer GmbH | 2016 | — |
| +1 | K181964 | JiveX | Visus Health IT GmbH | 2018 | — |
| +2 | K200703 | JiveX | Visus Health IT GmbH | 2020 | — |
| +3 | K212321 | JiveX (Model Number / Release: 5.3) | Visus Health IT GmbH | 2021 | — |
| +4 | K231041 | JiveX (Model Number / Release: 5.4) | Visus Health IT GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K142750 | JiveXSummary page 5…veX 5.0 with the predicate devices JiveX 4.7 JiveX 5.0 SE: JiveX 4.7 510(k) number K162008 K142750 Manufacturer VISUS Technology Transfer GmbH VISUS Technology Transfer GmbH Design/Architect. client / server… | 2015 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181964 | JiveX | 2018 | 3 |
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 5 companies; a new generation was cleared every 1.5 years on median.
- 15 of the 28 ancestors have a recall of any class.
- Of its descendants, K181964 (Visus Health IT GmbH, 2018) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K142750.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
JiveX is a software only Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL7 data, including mammographic images, and bio signals. JiveX also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive. It supports the physician in diagnosis. For primary image diagnosis in…
Read the full statement (125 words)
JiveX is a software only Picture Archiving and Communication System intended to display, process, read, report,
communicate, distribute, store, and archive medical data which is available as DICOM or HL7 data, including
mammographic images, and bio signals. JiveX also converts case related non-image documents, archives them as DICOM
data and serves as a vendor neutral archive.
It supports the physician in diagnosis.
For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images must be used. Also
monitors (displays) and printers which received FDA clearance for Mammography must be used.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical
technicians, and assistants.
Note: Web-based image distribution and mobile device display are not intended for diagnostic purposes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162008: JiveX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162008
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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