# K254120: SubtleHD-CT (1.x)

- Pathway: 510(k) (Traditional)
- Applicant: Subtle Medical, Inc.
- Decided: May 15, 2026 after 147 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 6 generations back to K922470 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212074: ClariCT.AI, Claripi, Inc. (2021) Summary page 5.

## Indications for use
SubtleHD-CT is an AI/ML software intended for the processing and enhancement of CT images regardless of the manufacturer or model of CT scanner.

Source page: https://510kreport.com/device/K254120
Methodology: https://510kreport.com/methodology