# K141480: CVI42

- Pathway: 510(k) (Traditional)
- Applicant: Circle Cardiovascular Imaging, Inc.
- Decided: Aug 22, 2014 after 79 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) iNtuition: named in the summary without a submission number

## Most influential descendants
- K213998: cvi42 Auto Imaging Software Application (2022), 7 descendants of its own
- K243038: Salix Central (2025), 1 descendant of its own
- K222854: iTFlow (2023), 1 descendant of its own
- K212565: CoverScan v1 (2022), 1 descendant of its own
- K251027: cvi42 Coronary Plaque Software Application (2025), 0 descendants of its own

## Indications for use
Cvi42 vascular analysis add-on is an image analysis software package add-on for evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplaner reconstruction (MPR), thin/think maximum intensity projection (MIP) thin and think, inverted MIP thin and think, volume rendering technique (VRT), curved planner reformation, 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 conforming the presence or absence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions. It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR 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 the cvi42 is not restricted.

Source page: https://510kreport.com/device/K141480
Methodology: https://510kreport.com/methodology