# K210999: SwiftMR

- Pathway: 510(k) (Traditional)
- Applicant: Airs Medical, Inc.
- Decided: Oct 14, 2021 after 195 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.
6 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191688: SubtleMR, Subtle Medical, Inc. (2019) Summary page 4.

## Most influential descendants
- K220416: SwiftMR (2022), 4 descendants of its own
- K230854: SwiftMR (2023), 3 descendants of its own
- K253775: SwiftMR (2026), 1 descendant of its own
- K261349: SwiftMR (2026), 0 descendants of its own
- K241982: DeepFoqus (DeepFoqus-Accelerate) (2025), 0 descendants of its own

## Indications for use
SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of brain MRI images in DICOM format. It can be used for noise reduction and increasing image sharpness for non-contrast enhanced MRI images. SwiftMR is not intended for use on mobile devices.

Source page: https://510kreport.com/device/K210999
Methodology: https://510kreport.com/methodology