510(k) · Cleared
ClearedCSV12 Software Viewer
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 Oct 3, 2002 as substantially equivalent to K021497 (Acuson Corp., 2002) after a 30-day review. Its family tree reaches back 4 generations to 1994. 104 later devices descend from it.
- Decided
- Oct 3, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K934041 (1994). 8 ancestors in all, the oldest K891689 (1989). 104 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 3 generations backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- 2 generations backK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- 1 generation backK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- This deviceK022896 CSV12 Software ViewerAcuson Corp. · 2002
- Descendant · cites it directly · 102 of its ownK052895 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
Showing 5 of 104 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 104 · See all- K052895Foursight Viewtool Image ViewerSiemens Medical Solutions USA, Inc. · 2005 · cites it directly102descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K934041 | Hewlett Packard Conos Ultrasound Imaging System Modification | Hewlett-Packard Co. | 1994 | — |
| −3 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| −2 | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| −1 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| 0 (this device) | K022896 | CSV12 Software Viewer | Acuson Corp. | 2002 | — |
| +1 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 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 |
|---|---|---|---|
| * | K021497 | Cypress Ultrasound SystemSummary page 1…l Name: Picture Archival and Communications System Classification: Picture Archival and Communications System (LLZ) class II (21CFR 9892.2050) Predicate Device: K021497, July 09, 2002, cleared as the Acuson Cypress System Device Description: This modification is a software-only version of the Acu… | 2002 |
| * | — | Cypress Diagnostic Ultrasound System Image Viewer Named without a submission number |
What descends from it? (104)
See all 1043 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 8 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K052895 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 102 descendants of its own.
- 4 other devices also cite its predicate K021497.
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 CSV12 Software Viewer is for the acceptance,
transfer, display, storage, and digital processing of Cypress Diagnostic Ultrasound
System images, including image manipulation and quantification.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022896: CSV12 Software Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022896
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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