# K243250: SubtleHD (1.x)

- Pathway: 510(k) (Traditional)
- Applicant: Subtle Medical, Inc.
- Decided: Feb 12, 2025 after 120 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: 8 generations back to K922470 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230854: SwiftMR, Airs Medical, Inc. (2023) Summary page 5.
- K223623: SubtleMR (2.3.x), Subtle Medical, Inc. (2023) Summary page 5.

## Indications for use
SubtleHD is an image processing software that can be used for image enhancement of all body parts MRI images. It can be used for noise reduction and increasing image sharpness.

Source page: https://510kreport.com/device/K243250
Methodology: https://510kreport.com/methodology