510(k) · Cleared
Clearedcvi42 Auto Imaging 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 Jul 28, 2022 as substantially equivalent to K082628 (Circle Cardiovascular Imaging, Inc., 2008) and 2 other predicates after a 219-day review. Its family tree reaches back 7 generations to 1995. 7 later devices descend from it.
- Decided
- Jul 28, 2022
- Review
- 219 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K945512 (1995). 23 ancestors in all, the oldest K924605 (1993). 7 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 6 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 5 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 4 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 3 generations backK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
- 2 generations backK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
- 1 generation backK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- This deviceK213998 cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK243038 Salix CentralArtrya Limited · 2025
- Descendant · cites it directly · 0 of its ownK251027 cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK251837 Salix Coronary Plaque (V1.0.0)Artrya Limited · 2025
- Descendant · cites it directly · 0 of its ownK241922 MyomicsPhantomics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK242062 1CMR ProMycardium AI Limited · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K243038Salix CentralArtrya Limited · 2025 · cites it directly1descendant
- K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc. · 2025 · cites it directly0descendants
- K251837Salix Coronary Plaque (V1.0.0)Artrya Limited · 2025 · 2 generations on0descendants
- K241922MyomicsPhantomics, Inc. · 2025 · cites it directly0descendants
- K2420621CMR ProMycardium AI Limited · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −6 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −5 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −4 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −3 | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
| −2 | K083446 | Cardiac Function Analysis, Calcium Scoring | Ziosoft, Inc. | 2009 | — |
| −1 | K111373 | CT42 Cardiac Computed Tomography (CT) Software | Circle Cardiovascular Imaging, Inc. | 2011 | — |
| 0 (this device) | K213998 | cvi42 Auto Imaging Software Application | Circle Cardiovascular Imaging, Inc. | 2022 | — |
| +1 | K243038 | Salix Central | Artrya Limited | 2025 | — |
| +1 | K251027 | cvi42 Coronary Plaque Software Application | Circle Cardiovascular Imaging, Inc. | 2025 | — |
| +2 | K251837 | Salix Coronary Plaque (V1.0.0) | Artrya Limited | 2025 | — |
| +1 | K241922 | Myomics | Phantomics, Inc. | 2025 | — |
| +1 | K242062 | 1CMR Pro | Mycardium AI Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 0 |
| 2025 | 4 | 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 K233925 Relu Creatorscore 22.5 · 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? (3)
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 4…Regulation Number: 21 CFR 892.2050 III. PREDICATE DEVICES The primary predicate is cmr42 manufactured by Circle Cardiovascular Imaging Inc. under K082628. cvi42, manufactured by Circle Cardiovascular Imaging Inc. under K141480, is used as a secondary predicate device and ct42, manuf… | 2008 |
| * | K141480 | CVI42Summary page 4…DEVICES The primary predicate is cmr42 manufactured by Circle Cardiovascular Imaging Inc. under K082628. cvi42, manufactured by Circle Cardiovascular Imaging Inc. under K141480, is used as a secondary predicate device and ct42, manufactured by Circle Cardiovascular Imaging Inc. under K111373, is used as a… | 2014 |
| * | K111373 | CT42 Cardiac Computed Tomography (CT) SoftwareSummary page 4…ufactured by Circle Cardiovascular Imaging Inc. under K141480, is used as a secondary predicate device and ct42, manufactured by Circle Cardiovascular Imaging Inc. under K111373, is used as a tertiary predicate device. The predicate devices have not been subject to a design-related recall. Circle Cardio… | 2011 |
What descends from it? (7)
6 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 27 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K243038 (Artrya Limited, 2025) has gone furthest, with 1 descendant of its own.
- 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. 2022, 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 Auto is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables a set of tools to assist physicians in qualitative assessment of cardiac images and quantitative measurements of the heart and adjacent vessels; perform calcium scoring; and to confirm the…
Read the full statement (148 words)
cvi42 Auto is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format.
It enables a set of tools to assist physicians in qualitative assessment of cardiac images and quantitative measurements of the heart and adjacent vessels; perform calcium scoring; and to confirm the presence or absence of physician-identified lesion in blood vessels.
The target population for cvi42 Auto's manual workflows is not restricted; however, cvi42 Auto's semi-automated machine learning algorithms are intended for an adult population.
cvi42 Auto shall be used only for cardiac images acquired from an MR or CT scanner. It 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.
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/K213998 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213998: cvi42 Auto Imaging Software Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213998
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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