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FDA-cleared K253775

SwiftMR

Airs Medical, Inc.

Authorized purpose: MRI image enhancement through noise reduction and sharpening; clinicians retain responsibility for final patient management decisions.

Modality
MRI
Anatomy
Whole Body
Decision
2026-03-26
FDA-cleared K251483

SwiftSight-Brain

AIRS Medical Inc.

Authorized purpose: Adjunctive brain MRI morphometry and lesion-quantification support for qualified healthcare professionals, including segmented overlays, volumetric measurements, normative percentiles and longitudinal comparison.

Modality
MRI
Anatomy
Brain
Decision
2025-09-23
FDA-cleared K230854

SwiftMR

AIRS Medical Inc.

Authorized purpose: Accept, enhance, and transfer all-body MR images in DICOM format using noise reduction and image sharpening; it is not intended for mobile devices.

Modality
MRI
Anatomy
All body parts, including the body, cardiac, neuro, and musculoskeletal regions represented in validation.
Decision
2023-10-27
FDA-cleared K220416

SwiftMR

AIRS Medical Inc.

Authorized purpose: SwiftMR is image-processing software that enhances supported MRI DICOM images by reducing noise or increasing sharpness within the labeled workflow; exact scanner, sequence, algorithm, and output limits are submission-specific.

Modality
MRI
Anatomy
Multi-region
Decision
2022-05-25
FDA-cleared K210999

SwiftMR

AIRS Medical Inc.

Authorized purpose: SwiftMR is image-processing software that enhances supported MRI DICOM images by reducing noise or increasing sharpness within the labeled workflow; exact scanner, sequence, algorithm, and output limits are submission-specific.

Modality
MRI
Anatomy
Multi-region
Decision
2021-10-14