FDA.reportPublic FDA data

AIRS Medical Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30248201863024820186AIRS Medical Inc.1N2026-01-0113-14F, Keungil Tower 223, Teheran-ro, Gangnam-gu Seoul KR 06142

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3105001397472526K253775SwiftMRQIH2026-03-26
3105001889734827K251483SwiftSight-BrainQIH2025-09-23
3105001437956810K230854SwiftMRLLZ2023-10-27
3105001422796129K220416SwiftMRLLZ2022-05-25
3105001975243946K210999SwiftMRLLZ2021-10-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ32023-10-27
QIH22026-03-26

PMN#

SwiftMR

2023-10-27

Airs Medical, Inc.

GUDID#

SwiftMR - 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.

AIRS Medical Inc.

2026-04-01