# K191688: SubtleMR

- Pathway: 510(k) (Traditional)
- Applicant: Subtle Medical, Inc.
- Decided: Sep 16, 2019 after 84 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: 4 generations back to K922470 (1992). 4 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172768: ZOOM, Zetta Medical Technologies, LLC (2018) Summary page 4.

## Most influential descendants
- K210999: SwiftMR (2021), 6 descendants of its own
- K203182: SubtleMR (2021), 6 descendants of its own
- K202404: BoneMRI (2021), 5 descendants of its own
- K221762: BoneMRI v1.4 (2022), 4 descendants of its own
- K220416: SwiftMR (2022), 4 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 and knee MRI, or increase image sharpness for non-contrast enhanced head MRI.

Source page: https://510kreport.com/device/K191688
Methodology: https://510kreport.com/methodology