510(k) · Cleared
ClearedJiveX (Model Number / Release: 5.4)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visus Health IT GmbH · LLZ System, Image Processing, Radiological
Cleared on Jul 14, 2023 as substantially equivalent to K212321 (Visus Health IT GmbH, 2021) after a 93-day review. Its family tree reaches back 14 generations to 1997.
- Decided
- Jul 14, 2023
- Review
- 93 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K971684 (1997). 32 ancestors in all, the oldest K945188 (1995). No later device cites it as a predicate yet.
- Root · 14 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 10 generations between
- 3 generations backK181964 JiveXVisus Health IT GmbH · 2018
- 2 generations backK200703 JiveXVisus Health IT GmbH · 2020
- 1 generation backK212321 JiveX (Model Number / Release: 5.3)Visus Health IT GmbH · 2021
- This deviceK231041 JiveX (Model Number / Release: 5.4)Visus Health IT GmbH · 2023
Show all 14 generations
- Root · 14 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 13 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 12 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 11 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 10 generations backK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- 9 generations backK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- 8 generations backK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- 7 generations backK101666 Syngo. Plaza VA20ASiemens AG Medical Solutions · 2010 · Recalled
- 6 generations backK132532 Syngo.Plaza VB10ASiemens AG Healthcare · 2013 · Recalled
- 5 generations backK142750 JiveXVisus Technology Transfer GmbH · 2015
- 4 generations backK162008 JiveXVisus Technology Transfer GmbH · 2016
- 3 generations backK181964 JiveXVisus Health IT GmbH · 2018
- 2 generations backK200703 JiveXVisus Health IT GmbH · 2020
- 1 generation backK212321 JiveX (Model Number / Release: 5.3)Visus Health IT GmbH · 2021
- This deviceK231041 JiveX (Model Number / Release: 5.4)Visus Health IT GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −13 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −12 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −11 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −10 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| −9 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| −8 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| −7 | K101666 | Syngo. Plaza VA20A | Siemens AG Medical Solutions | 2010 | 3 |
| −6 | K132532 | Syngo.Plaza VB10A | Siemens AG Healthcare | 2013 | 11 |
| −5 | K142750 | JiveX | Visus Technology Transfer GmbH | 2015 | — |
| −4 | K162008 | JiveX | Visus Technology Transfer GmbH | 2016 | — |
| −3 | K181964 | JiveX | Visus Health IT GmbH | 2018 | — |
| −2 | K200703 | JiveX | Visus Health IT GmbH | 2020 | — |
| −1 | K212321 | JiveX (Model Number / Release: 5.3) | Visus Health IT GmbH | 2021 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K212321 | JiveX (Model Number / Release: 5.3)Summary page 4…ology CFR Section 21 CFR §892.2050 Device Class Class II Product Code LLZ Predicate Device Predicate Device K212321 Trade Names JiveX Common Name Picture Archiving and Communication System (PACS) Classification… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 15 of the 32 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 (131 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.
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 of mammographic images are not intended for diagnostic purposes.
For users in the United States of America: Mobile device display is not intended for diagnostic purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231041 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231041: JiveX (Model Number / Release: 5.4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231041
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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