510(k) · Cleared
ClearedFoursight Viewtool Image Viewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 27, 2005 as substantially equivalent to K050034 (Siemens Medical Solutions USA, Inc., 2005) and 1 other predicate after a 13-day review. Its family tree reaches back 6 generations to 1995. 102 later devices descend from it.
- Decided
- Oct 27, 2005
- Review
- 13 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K935595 (1995). 30 ancestors in all, the oldest K891689 (1989). 102 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 5 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 4 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 3 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 2 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 1 generation backK050034 Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- This deviceK052895 Foursight Viewtool Image ViewerSiemens Medical Solutions USA, Inc. · 2005
- Descendant · cites it directly · 97 of its ownK060992 Syngo US WorkplaceSiemens Medical Solutions · 2006 · Recalled
- Descendant · 2 generations on · 95 of its ownK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 92 of its ownK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- Descendant · 4 generations on · 91 of its ownK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · 5 generations on · 45 of its ownK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K060992Syngo US WorkplaceSiemens Medical Solutions · 2006 · cites it directly97descendants
- K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on95descendants
- K130159Qlab Quantification Software Heart ModelPhilips Health Care · 2013 · 3 generations on92descendants
- K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · 4 generations on91descendants
- K171314QLAB Advanced Quantification SoftwarePhilips Health Care · 2017 · 5 generations on45descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −5 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −4 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −3 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −2 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −1 | K050034 | Sonoline Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| 0 (this device) | K052895 | Foursight Viewtool Image Viewer | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +1 | K060992 | Syngo US Workplace | Siemens Medical Solutions | 2006 | 1 |
| +2 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| +4 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
| +5 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 12 | 0 |
| 2021 | 7 | 0 |
| 2022 | 11 | 0 |
| 2023 | 8 | 0 |
| 2024 | 12 | 0 |
| 2025 | 17 | 0 |
| 2026 | 14 | 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? (2)
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 |
|---|---|---|---|
| * | K050034 | Sonoline Antares Diagnostic Ultrasound SystemSummary page 1…on Name: 21 CFR 892.2050 Picture Archiving and Communications System FR # 892.2050 Product Code 90-LLZ 3. Predicate Device: * K050034, 01/13/2005, ACUSON Antares ultrasound systems • K022896, 10/02/2002, CSV12 Viewer Software 4. Device Description… | 2005 |
| * | K022896 | CSV12 Software ViewerSummary page 1…ommunications System FR # 892.2050 Product Code 90-LLZ 3. Predicate Device: * K050034, 01/13/2005, ACUSON Antares ultrasound systems • K022896, 10/02/2002, CSV12 Viewer Software 4. Device Description: The ViewTool is used to view volumes and images, to sto… | 2002 |
What descends from it? (102)
See all 1022 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)
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 10 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 6 of the 30 ancestors have a recall of any class.
- Of its descendants, K060992 (Siemens Medical Solutions, 2006) has gone furthest, with 97 descendants of its own.
- 5 other devices also cite its predicate K050034.
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 fourSight ViewTool is for the acceptance, transfer, display,
storage, and digital processing of ultrasound images, including image manipulation and
quantification.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052895 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052895: Foursight Viewtool Image Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052895
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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