FDA.reportPublic FDA data

SwiftSight-Brain

Primary DI
08800124700129
Brand
SwiftSight-Brain
Company
AIRS Medical Inc.
Model
SS25-BR-CL
Published
2025-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251483000SwiftSight-BrainAirs Medical, Inc.2025-09-23QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800124700129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800124700129088001247001298800124700129

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA 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).

Regulatory Flags#

DUNS number
695823246
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800124700136SwiftMRA20-CL v3.1.X.X2026-04-01
08800124700105SwiftMRA22-OP2025-02-26
08800124700099SwiftMRA20-CL v3.0.X.X(v1.3.4.X(US))2023-05-19
08800124700075SwiftMRA20-CL v1.3.X.X2023-01-29
08800124700006SwiftMRA20-CL v1.3.X.X2022-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850018318075AI Platform IIExo Imaging, Inc.QIH2026-10-22
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03770033463055FETOLYDIAGNOLYQIH2026-10-22
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