510(k) · Cleared
ClearedCorview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marrek, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 21, 2013 as substantially equivalent to K120135 (Tomtec Imaging Systems GmbH, 2012) and 1 other predicate after a 119-day review. Its family tree reaches back 13 generations to 1995.
- Decided
- Aug 21, 2013
- Review
- 119 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K935595 (1995). 73 ancestors in all, the oldest K900889 (1990). No later device cites it as a predicate yet.
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations between
- 3 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- 1 generation backK120135 2D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012
- This deviceK131158 CorviewMarrek, Inc. · 2013
Show all 13 generations
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 11 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 10 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 9 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 3 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- 1 generation backK120135 2D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012
- This deviceK131158 CorviewMarrek, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −12 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −11 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −10 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −9 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −7 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −4 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −3 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −2 | K090461 | Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 | Tomtec Imaging Systems GmbH | 2009 | 1 |
| −1 | K120135 | 2D Cardiac Performance Analysis MR 1.0 | Tomtec Imaging Systems GmbH | 2012 | — |
| 0 (this device) | K131158 | Corview | Marrek, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 11 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K120135 | 2D Cardiac Performance Analysis MR 1.0Summary page 1…communications system, Product Code LLZ Legally Marketed Predicate 1. 2D Cardiac Performance Analysis MR 1.0 device Device: (K1 20135), manufactured by TomTec Imaging Systems 2. Virtue (CORE Module) (K1 11833). man… | 2012 |
| * | K111833 | VirtueSummary page 1…ysis MR 1.0 device Device: (K1 20135), manufactured by TomTec Imaging Systems 2. Virtue (CORE Module) (K1 11833). manufactured by Diagnosoft, Inc. Description of New CORVIEW Device: CORVIEW is an independent soft… | 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 18 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 17 of the 73 ancestors have a recall of any class.
- 2 other devices also cite its predicate K120135.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Corview software application is indicated for viewing and post-processing of cardiovascular magnetic resonance images (MRIs) to obtain Left Atrial Enhancement (LAE) quantification and visualization on a 3D model. It provides measurements of LAE within the left atrial wall. It enables: * Importing Cardiac MRIs in DICOM format * Qualitative analysis of the cardiac MRIs using display functionality such as panning, windowing, zooming, and navigation…
Read the full statement (170 words)
The Corview software application is indicated for viewing and post-processing of cardiovascular magnetic resonance images (MRIs) to obtain Left Atrial Enhancement (LAE) quantification and visualization on a 3D model. It provides measurements of LAE within the left atrial wall.
It enables:
* Importing Cardiac MRIs in DICOM format
* Qualitative analysis of the cardiac MRIs using display functionality such as panning, windowing, zooming, and navigation through series/slices and phases
* Quantitative measurement in cardiac MRIs, specifically LAE
It is intended for use by qualified medical professionals experienced in examining and evaluating cardiovascular MRIs, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process.
The target population of Corview is not restricted. However image acquisition by an MRI scanner with cardiac capability may limit the use of the device for certain sectors of the general public.
Corview is intended to view only cardiac magnetic resonance images acquired from an MRI scanner with cardiac capabilities.
The CORVIEW software application is intended for use in the clinical setting.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131158: Corview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131158
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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