SwiftMR

GUDID 08800124700099

AIRS Medical Inc.

Radiology DICOM image processing application software

• Primary Device ID: 08800124700099
• NIH Device Record Key: 2cfd0747-f7ed-427c-83b6-a74e39084dea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SwiftMR
• Version Model Number: A20-CL v3.0.X.X(v1.3.4.X(US))
• 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	08800124700099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220416

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: 2023-05-29
• Device Publish Date: 2023-05-19

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