# K230854: SwiftMR

- Pathway: 510(k) (Traditional)
- Applicant: Airs Medical, Inc.
- Decided: Oct 27, 2023 after 213 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: 7 generations back to K922470 (1992). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220416: SwiftMR, Airs Medical, Inc. (2022) Summary page 4.

## Most influential descendants
- K253775: SwiftMR (2026), 1 descendant of its own
- K261349: SwiftMR (2026), 0 descendants of its own
- K243250: SubtleHD (1.x) (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 all body parts MR images in DICOM format. It can be used for noise reduction and increasing image sharpness for MR images. SwiftMR is not intended for use on mobile devices.

Source page: https://510kreport.com/device/K230854
Methodology: https://510kreport.com/methodology