SwiftMR

Basic Information

• Brand Name: SwiftMR
• Primary DI: 08800124700136
• Version / Model: A20-CL v3.1.X.X
• Company Name: AIRS Medical Inc.
• Labeler DUNS: 695823246
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-01
• Public Version: 1
• Public Version Date: 2026-04-09
• Public Version Status: New
• Public Device Record Key: 4781a2cf-bbd6-447d-862a-a8d29e410548

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QIH	Automated Radiological Image Processing Software	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57812	Radiology DICOM image processing application software	A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800124700136	GS1

Premarket Submissions

Submission Number	Supplement Number
K253775	000