SwiftMR

GUDID 08800124700105

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.

AIRS Medical Inc.

Radiology DICOM image processing application software

• Primary Device ID: 08800124700105
• NIH Device Record Key: 3e2e6506-b916-4668-ae9c-e55c7372671c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SwiftMR
• Version Model Number: A22-OP
• Company DUNS: 695823246
• Company Name: AIRS Medical Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800124700105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230854

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-06
• Device Publish Date: 2025-02-26

On-Brand Devices [SwiftMR]

• 08800124700006: A20-CL v1.3.X.X
• 08800124700075: A20-CL v1.3.X.X
• 08800124700099: A20-CL v3.0.X.X(v1.3.4.X(US))
• 08800124700105: SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and t