510(k) · Cleared
Recalled · Class II · 2016Kinetdx Picture Archiving and Communications System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acuson Corp. · LLZ System, Image Processing, Radiological
Cleared on Nov 22, 2002 as substantially equivalent to K980060 (Mpacs, LLC, 1998) and 2 other predicates after a 10-day review. Its family tree reaches back 3 generations to 1995. 16 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 22, 2002
- Review
- 10 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 3 generations to K950279 (1995). 6 ancestors in all, the oldest K925965 (1993). 16 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
- 2 generations backK964803 Univision Echocardiology SystemNetwork Concepts, Inc. · 1997
- 1 generation backK980060 EcholinkMpacs, LLC · 1998
- This deviceK023772 Kinetdx Picture Archiving and Communications SystemAcuson Corp. · 2002
- Descendant · cites it directly · 13 of its ownK041029 KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 7 of its ownK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 6 of its ownK111319 Ibis Explorer and Markup SoftwareMedqia · 2011
- Descendant · 4 generations on · 5 of its ownK122205 EXINIExini Diagnostics AB · 2012
- Descendant · 2 generations on · 3 of its ownK050943 GE ViewpointGeneral Electric Co. · 2005 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K041029KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · cites it directly13descendants
- K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · 2 generations on7descendants
- K111319Ibis Explorer and Markup SoftwareMedqia · 2011 · 3 generations on6descendants
- K122205EXINIExini Diagnostics AB · 2012 · 4 generations on5descendants
- K050943GE ViewpointGeneral Electric Co. · 2005 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950279 | TOMTECP90 | Tomtec Imaging Systems, Inc. | 1995 | — |
| −2 | K964803 | Univision Echocardiology System | Network Concepts, Inc. | 1997 | — |
| −1 | K980060 | Echolink | Mpacs, LLC | 1998 | — |
| 0 (this device) | K023772 | Kinetdx Picture Archiving and Communications System | Acuson Corp. | 2002 | — |
| +1 | K041029 | Kinetdx | Siemens Medi Cal Solutions, Inc. | 2004 | 1 |
| +2 | K053133 | Syngo Dynamics, Version 5.0 | Siemens Medical Solutions USA, Inc. | 2005 | 2 |
| +3 | K111319 | Ibis Explorer and Markup Software | Medqia | 2011 | — |
| +4 | K122205 | EXINI | Exini Diagnostics AB | 2012 | — |
| +2 | K050943 | GE Viewpoint | General Electric Co. | 2005 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 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 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? (3)
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 |
|---|---|---|---|
| * | K980060 | EcholinkSummary page 1…Picture Archival and Communications System Classification: Picture Archival and Communications System (LLZ) class II(21CFR $892.2050) Predicate Device: EchoLink, K980060 cleared on February 25,1998 ALI UltraPacs, K925965 cleared on June 14, 1993 ALI DataComPacs Module, K963610, cleared on November… | 1998 |
| * | K925965 | Picture Archiving and Communication SystemsSummary page 1…lassification: Picture Archival and Communications System (LLZ) class II(21CFR $892.2050) Predicate Device: EchoLink, K980060 cleared on February 25,1998 ALI UltraPacs, K925965 cleared on June 14, 1993 ALI DataComPacs Module, K963610, cleared on November 27,1996 Device Description: KinetDx is a picture a… | 1993 |
| * | K963610 | Aki Compacs Data Compresion Module for Diagnostic ImagesSummary page 1…(LLZ) class II(21CFR $892.2050) Predicate Device: EchoLink, K980060 cleared on February 25,1998 ALI UltraPacs, K925965 cleared on June 14, 1993 ALI DataComPacs Module, K963610, cleared on November 27,1996 Device Description: KinetDx is a picture archival and communications system (PACS) that includes a… | 1996 |
What descends from it? (16)
See all 163 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 14, 2016 | Class II | Z-1601-2016 | Software design | Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward … |
| Jan 29, 2016 | Class II | Z-0826-2016 | Software design | Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients. |
| Jan 25, 2016 | Class II | Z-1183-2016 | Software design | Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics. |
| Apr 3, 2014 | Class II | Z-1613-2014 | Software design | Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display. |
| Jan 27, 2014 | Class II | Z-1216-2014 | Software design | Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K041029 (Siemens Medi Cal Solutions, Inc., 2004) has gone furthest, with 13 descendants of its own.
- 4 other devices also cite its predicate K980060.
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?
The intended use of the KinetD, is for the acceptance, transfer, display, storage, arid digital processing of diagnostic ultrasound, CT, MRI, and X-ray angiography images, including manipulation and quantification of the images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023772 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023772: Kinetdx Picture Archiving and Communications System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023772
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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