FDA.reportPublic FDA data

Venue

Primary DI
00840682139212
Brand
Venue
Company
GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC
Model
R2 UPG
Device description
Upgrade Venue R1 to R2 MD either eDelivery or physical
Published
2018-06-08
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
K180599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180599000VenueGE Medical Systems Ultrasound and Primary Care Diagnostics2018-05-02IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682139212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682139212008406821392128406821392120840682139212

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080418188
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953100509Automated Aortic StenosisA-1.02026-05-05
00195278516480VenueR42022-06-30
00195278516497Venue FitR42022-06-30
00195278516510Venue GoR42022-06-27
00195278384041LOGIQE10 R32021-11-15
00195278194275Venue FitR32021-01-11
00195278005830VenueR3 UPG2020-11-24
00195278005861Venue GOR3 UPG2020-11-24
00840682190503Venue GoR32020-11-24
00840682100038InveniaABUS WorkstationH5014WS2014-09-24
00840682123815VenueR12017-07-14
00840682138260LOGIQE102018-02-27
00840682138840Venue GoR22019-02-25
00840682138888VenueR22018-06-08
00840682141161InveniaABUS 2.02018-09-04
00840682100090InveniaABUS Review Software2016-01-29
00195278439352LOGIQE10 R1 to R3 UPG2025-12-05
00195278439369LOGIQE10 R2 to R3 UPG2025-12-05
00840682147118LOGIQE10 R1 to R2 UPG2020-05-26
00195278513014Venue FitR4 UPG2022-06-30

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
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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
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08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYN2026-05-29