# K200274: CariCloud

- Pathway: 510(k) (Traditional)
- Applicant: Caristo Diagnostics
- Decided: May 21, 2020 after 107 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
Longest line of descent: 8 generations back to K913770 (1991). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121916: Intuition, Terarecon,Inc. (2013) Summary page 4.

## Indications for use
The indications for use, are as follows: CariCloud is a software device used by operators to evaluate attenuation in the coronary arteries and surrounding tissue in CCTA images. CariCloud is to be used by trained operators. CariCloud analysis results are to be used by Healthcare Professionals and may assist in diagnosis. CariCloud analysis results are indicated for use for all patients referred for CCTA imaging.

Source page: https://510kreport.com/device/K200274
Methodology: https://510kreport.com/methodology