# K223623: SubtleMR (2.3.x)

- Pathway: 510(k) (Traditional)
- Applicant: Subtle Medical, Inc.
- Decided: May 11, 2023 after 157 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: 6 generations back to K922470 (1992). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203182: SubtleMR, Subtle Medical, Inc. (2021) Summary page 4.

## Most influential descendants
- K243250: SubtleHD (1.x) (2025), 0 descendants of its own
- K241681: Overjet Image Enhancement Assist (2024), 0 descendants of its own
- K240290: AiMIFY (1.x) (2024), 0 descendants of its own

## Indications for use
SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI, or increase image sharpness for head MRI.

Source page: https://510kreport.com/device/K223623
Methodology: https://510kreport.com/methodology