Class Class II
cvi42 Software Application (K242781)
Description
cvi42 Software Application by Circle Cardiovascular Imaging, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242781
Clearance Date2024-10-15
Clearance TypeSpecial
Product CodeQIH
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242781
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. cvi42 Software Application (K242781) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241038 | Cardiac CT Function Software Application | Circle Cardiovascular Imaging | 2024 |
| K232661 | Myocardial Strain Software Application | Circle Cardiovascular Imaging | 2023 |
| K213998 | cvi42 Auto Imaging Software Application | Circle Cardiovascular Imaging, Inc. | 2022 |
| K141480 | CVI42 | Circle Cardiovascular Imaging, Inc. | 2014 |
| K111373 | CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE | Circle Cardiovascular Imaging, Inc. | 2011 |
| K092628 | ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSIO... | Alan Reid | 2010 |
| K082628 | CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 | Circle Cardiovascular Imaging, Inc. | 2008 |
Trace the full predicate network for K242781
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.