# K253775: SwiftMR

- Pathway: 510(k) (Traditional)
- Applicant: Airs Medical, Inc.
- Decided: Mar 26, 2026 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). 8 ancestors in all.
1 later device descends from it; 1 cites 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)
- K230854: SwiftMR, Airs Medical, Inc. (2023) Summary page 5.

## Most influential descendants
- K261349: SwiftMR (2026), 0 descendants of its own

## Indications for use
SwiftMR is a stand-alone medical imaging software solution intended for the acceptance, enhancement, processing, review, analysis, communication, and transfer of all body parts MR images in DICOM format. The software may be used for the enhancement of medical images, such as noise reduction and increased image sharpness for MR images. The device is designed for use by healthcare professionals and is intended to assist clinicians, who remain responsible for making all final patient management decisions. The device is not intended for use on mobile devices. The available field strengths are as follows: 0.25T, 0.31T, 0.4T, 0.55T, 0.6T, 1.5T, and 3.0T.

Source page: https://510kreport.com/device/K253775
Methodology: https://510kreport.com/methodology