FDA.reportPublic FDA data

Vscan

Primary DI
00198953079249
Brand
Vscan
Company
GE Vingmed Ultrasound A/S
Model
Air R3.1 for Android
Device description
Vscan Air R3.1 for Android
Published
2025-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250087000Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics2025-05-01IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953079249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953079249001989530792491989530792490198953079249

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
518870571
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953157145Vscan AirR3.2 for Android2026-05-11
00198953157152Vscan AirR3.2 for iOS2026-05-11
00195278875860VscanAir CL2025-07-04
00840682146647VividE80 v204 with OLED2020-08-12
00840682146661VividE80 v204 with LCD2020-08-12
00840682146678VividE90 v204 with OLED2020-08-12
00840682146692VividE90 v204 with LCD2020-08-12
00198953079256VscanAir R3.1 for iOS2025-11-17
00195278951700EchoPACSoftware Only v2102025-08-08
00195278951717EchoPACPlug-In v2102025-08-08
00195278916938VividPioneer v2102025-08-07
00195278884725VscanAir R3 for Android2025-05-22
00195278884749VscanAir R3 for iOS2025-05-22
00195278640550VscanAir R2 for iOS2023-09-26
00195278640567VscanAir R2 for Android2023-09-26
00195278640574VscanAir R2 CL2023-09-26
00195278660701VscanAir SL2023-09-26
00195278505330VividE95 v2062022-09-20
00195278504302EchoPACSoftware Only v2062022-08-23
00195278504326EchoPACPlug-in v2062022-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06903053124348Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124355Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124379Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124430Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124461Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124492Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124546Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124560Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124591Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124607Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124614Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124683Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124706Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124720Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124775Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124829Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYO2026-06-01
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYN2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYO2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYN2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYN2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYN2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYN2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYN2026-05-29