510(k) · Cleared
Clearedcvi42 Software Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circle Cardiovascular Imaging, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Oct 15, 2024 as substantially equivalent to K082628 (Circle Cardiovascular Imaging, Inc., 2008) and 5 other predicates after a 29-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- Oct 15, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K935595 (1995). 121 ancestors in all, the oldest K900889 (1990). No later device cites it as a predicate yet.
- Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations between
- 3 generations backK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- 2 generations backK120135 2D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012
- 1 generation backK232661 Myocardial Strain Software ApplicationCircle Cardiovascular Imaging · 2023
- This deviceK242781 cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc. · 2024
Show all 14 generations
- Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 13 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 12 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 11 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 10 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 9 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 8 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 5 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 4 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 3 generations backK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- 2 generations backK120135 2D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012
- 1 generation backK232661 Myocardial Strain Software ApplicationCircle Cardiovascular Imaging · 2023
- This deviceK242781 cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −13 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −12 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −11 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −10 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −9 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −8 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −5 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −4 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −3 | K090461 | Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 | Tomtec Imaging Systems GmbH | 2009 | 1 |
| −2 | K120135 | 2D Cardiac Performance Analysis MR 1.0 | Tomtec Imaging Systems GmbH | 2012 | — |
| −1 | K232661 | Myocardial Strain Software Application | Circle Cardiovascular Imaging | 2023 | — |
| 0 (this device) | K242781 | cvi42 Software Application | Circle Cardiovascular Imaging, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 4 | 0 |
| 1999 | 8 | 0 |
| 2000 | 13 | 0 |
| 2001 | 7 | 0 |
| 2002 | 11 | 0 |
| 2003 | 4 | 0 |
| 2004 | 14 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K082628 | CMR42 Cardiac Mri Imaging System, 2.1.23Summary page 6…Product Codes: QIH, LLZ Regulation Number: 21 CFR 892.2050 III. PREDICATE DEVICE The primary predicate is cmr42 under K082628, and the additional predicates are ct42 under K111373, cvi42 vascular add-on under K141480, cvi42 Auto under K213998, Strain Modu… | 2008 |
| * | K111373 | CT42 Cardiac Computed Tomography (CT) SoftwareSummary page 6…Regulation Number: 21 CFR 892.2050 III. PREDICATE DEVICE The primary predicate is cmr42 under K082628, and the additional predicates are ct42 under K111373, cvi42 vascular add-on under K141480, cvi42 Auto under K213998, Strain Module under 232661, and CT Function under 241038. Each of… | 2011 |
| * | K141480 | CVI42Summary page 6…R 892.2050 III. PREDICATE DEVICE The primary predicate is cmr42 under K082628, and the additional predicates are ct42 under K111373, cvi42 vascular add-on under K141480, cvi42 Auto under K213998, Strain Module under 232661, and CT Function under 241038. Each of the predicate devices are manufactur… | 2014 |
| * | K213998 | cvi42 Auto Imaging Software ApplicationSummary page 6…EDICATE DEVICE The primary predicate is cmr42 under K082628, and the additional predicates are ct42 under K111373, cvi42 vascular add-on under K141480, cvi42 Auto under K213998, Strain Module under 232661, and CT Function under 241038. Each of the predicate devices are manufactured by Circle Cardiovascula… | 2022 |
| * | K232661 | Myocardial Strain Software ApplicationSummary page 11…nt in indications for use / intended use, technological characteristics, functionality, and operating principles with the predicates (K092628, K111373, K141480, K213998, K232661, and K241038). Of the three characteristics (technical, biological, and clinical) required for the demonstration of equivalence,… | 2023 |
| * | K241038 | Cardiac CT Function Software ApplicationSummary page 11…ions for use / intended use, technological characteristics, functionality, and operating principles with the predicates (K092628, K111373, K141480, K213998, K232661, and K241038). Of the three characteristics (technical, biological, and clinical) required for the demonstration of equivalence, biological ch… | 2024 |
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 29 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 21 of the 121 ancestors have a recall of any class.
- 4 other devices also cite its predicate K082628.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
cvi42 is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) images and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables: * Importing cardiac MR & CT Images in DICOM format. » Supporting clinical diagnostics by qualitative analysis of cardiac MR & CT images using display functionality such as panning…
Read the full statement (469 words)
cvi42 is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) images and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format.
It enables:
* Importing cardiac MR & CT Images in DICOM format.
» Supporting clinical diagnostics by qualitative analysis of cardiac MR & CT images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases, 3D reconstruction of images including multiplanar reconstructions of the images.
» Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac MR & CT images, specifically signal intensity, distance, area, volume, and mass.
» Supporting clinical diagnostics by using area and volume for measuring cardiac function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac MR & CT images.
» Flow quantifications based on velocity encoded cardiac MR images (including two and four dimensional flow analysis).
« Strain analysis of cardiac MR images by providing measurements of 2D LV myocardial function (displacement, velocity, strain, strain rate, time to peak, and torsion).
» Supporting clinical diagnostics of cardiac CT images including quantitative measurements of calcified plaques in the coronary arteries (calcium scoring), specifically Agatston and volume and mass calcium scores, visualization and quantitative measurement of heart structures including coronaries, femoral, aortic, and mitral valves.
» Evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplanar reconstruction (MPR), thin/thick maximum intensity projection (MIP), inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR), processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics) and key images. The software package is designed to support the physician in confirming the presence or absence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions.
cvi42 shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR or CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cvi42 is a software application that can be used as a stand-alone product or in a networked environment.
The target population for cvi42 and its manual workflows is not restricted; however, cvi42’'s semi-automated machine learning algorithms, included in the MR Function and CORE CT modules, are intended for an adult population. Further, image acquisition by a cardiac MR or CT scanner may limit the use of the software for certain sectors of the general public.
cvi42 shall not be used to view or analyze images of any part of the body except the cardiac images acquired from a cardiovascular magnetic resonance or computed tomography scanner.
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/K242781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242781: cvi42 Software Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242781
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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