510(k) · Cleared
ClearedSQuEEZ Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiowise, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 18, 2020 as substantially equivalent to K112531 (Vital Images, Inc., 2011) after a 221-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Dec 18, 2020
- Review
- 221 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K971684 (1997). 32 ancestors in all, the oldest K913770 (1991). No later device cites it as a predicate yet.
- Root · 9 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations between
- 3 generations backK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- 2 generations backK110366 Syngo.CT Cardiac FunctionSiemens AG · 2011 · Recalled
- 1 generation backK112531 Vitrea CT Myocardial AnalysisVital Images, Inc. · 2011
- This deviceK201250 SQuEEZ SoftwareCardiowise, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 7 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 5 generations backK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- 4 generations backK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- 3 generations backK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- 2 generations backK110366 Syngo.CT Cardiac FunctionSiemens AG · 2011 · Recalled
- 1 generation backK112531 Vitrea CT Myocardial AnalysisVital Images, Inc. · 2011
- This deviceK201250 SQuEEZ SoftwareCardiowise, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −8 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −7 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −6 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −5 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| −4 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| −3 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| −2 | K110366 | Syngo.CT Cardiac Function | Siemens AG | 2011 | 1 |
| −1 | K112531 | Vitrea CT Myocardial Analysis | Vital Images, Inc. | 2011 | — |
| 0 (this device) | K201250 | SQuEEZ Software | Cardiowise, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 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 21.6 · 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 |
|---|---|---|---|
| * | K112531 | Vitrea CT Myocardial AnalysisSummary page 5…1 of 3 6. Predicate Device Predicate Type 510(k) Number Device Name Manufacturer Primary Device K112531 VITREA CT VITAL IMAGES, MYOCARDIAL INC.… | 2011 |
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 23 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 13 of the 32 ancestors have a recall of any class.
- 3 other devices also cite its predicate K112531.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The SQuEEZ Software is an image analysis software application for cardiac Computer Tomography (CT) studies to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The software calculates a Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ) value to highlight and color code the wall motions of the heart. Tools are provided to display regional motion properties of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201250 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201250: SQuEEZ Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201250
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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