# K212074: ClariCT.AI

- Pathway: 510(k) (Special)
- Applicant: Claripi, Inc.
- Decided: Jul 27, 2021 after 25 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: 5 generations back to K922470 (1992). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183460: ClariCT.AI, Claripi, Inc. (2019) Summary page 4.

## Most influential descendants
- K254120: SubtleHD-CT (1.x) (2026), 0 descendants of its own
- K244002: AngioWaveNet (2025), 0 descendants of its own

## Indications for use
ClariCT.AI is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model.

Source page: https://510kreport.com/device/K212074
Methodology: https://510kreport.com/methodology