510(k) Report

510(k) · Cleared

Recalled · 2006

Sienet Diagnostic Reporting Console VA02 Upgrade

K935694510(k) TraditionalCleared Mar 7, 199498-day reviewClass II21 CFR 892.2050Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological

Cleared on Mar 7, 1994 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled 4 times.

Decided
Mar 7, 1994
Review
98 days
Class
Class II
Product code
LLZ
Recalls
4
Predicates
0

7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2004: 1 descendant cleared2005: 1 descendant cleared2007: 2 descendants cleared2006: 1 descendant cleared2014: 1 descendant cleared1990200020102020
  1. This deviceK935694 Sienet Diagnostic Reporting Console VA02 UpgradeSiemens Medical Solutions USA, Inc. · 1994
  2. Descendant · cites it directly · 6 of its ownK033831 Sienet CosmosSiemens AG Medical Solutions · 2003 · Recalled
  3. Descendant · 2 generations on · 5 of its ownK042832 Sienet Cosmos (Version V15A)Siemens AG Medical Solutions · 2004 · Recalled
  4. Descendant · 3 generations on · 2 of its ownK052461 Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005 · Recalled
  5. Descendant · 3 generations on · 1 of its ownK070755 InterworksAvreo, Inc. · 2007
  6. Descendant · 4 generations on · 0 of its ownK141556 Avreo Interworks SystemAvreo, Inc. · 2014

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 12006: 12007: 22014: 1
2003high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all
  • K033831Sienet CosmosSiemens AG Medical Solutions · 2003 · cites it directly6descendants
  • K042832Sienet Cosmos (Version V15A)Siemens AG Medical Solutions · 2004 · 2 generations on5descendants
  • K052461Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005 · 3 generations on2descendants
  • K070755InterworksAvreo, Inc. · 2007 · 3 generations on1descendant
  • K141556Avreo Interworks SystemAvreo, Inc. · 2014 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935694Sienet Diagnostic Reporting Console VA02 UpgradeSiemens Medical Solutions USA, Inc.1994—
+1K033831Sienet CosmosSiemens AG Medical Solutions20031
+2K042832Sienet Cosmos (Version V15A)Siemens AG Medical Solutions20043
+3K052461Syngo Imaging Version V20ASiemens AG Medical Solutions20053
+3K070755InterworksAvreo, Inc.2007—
+4K141556Avreo Interworks SystemAvreo, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200510
200610
200720
201410
FIG. 1 — Lineage of K935694, 1994–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033831Sienet CosmosSiemens AG Medical Solutions20036

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 5, 2006Not classifiedZ-0072-2007OtherPotential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.
Sep 5, 2006Not classifiedZ-0071-2007OtherPotential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.
Apr 1, 2004Not classifiedZ-1095-04OtherRecalling firm became aware of a potential problem through the submission of a product complaint to the firm reporting the Image Navigator feature in the MagicView 300 VA42A or VA42B software are not being imported accurately to certain…
Jul 3, 2003Not classifiedZ-0840-03OtherPotential error can occur with the 3D post processing options MPR, MIP, and VRT.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033831 (Siemens AG Medical Solutions, 2003) has gone furthest, with 6 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

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Recent decisions in LLZ

The LLZ category page

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  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
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https://510kreport.com/device/K935694 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935694: Sienet Diagnostic Reporting Console VA02 Upgrade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935694

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026