FDA.reportPublic FDA data

LOGIQ

Primary DI
00840682146944
Brand
LOGIQ
Company
GE Medical Systems (China) Co.,Ltd.
Model
e SW R9.2.X UPG
Published
2020-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K151028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151028000LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics2015-06-18IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682146944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682146944008406821469448406821469440840682146944

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)4371171xx@xx.xx

Regulatory Flags#

DUNS number
654658731
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682116978Achilles EXPIIv12016-06-27
00195278644152N/ARAB7-DH48062AN2025-01-09
00195278783295Vividiq v2082025-03-06
00195278797551Vividiq v206 to v208 SW only upgrade kit2025-03-06
00195278796455VividT9 v2082025-03-06
00195278796462VividT8 v2082025-03-06
00195278797513Vividiq v206 to v208 HW and SW upgrade kit2025-03-06
00195278833570VividT8 T9 v206 to v208 SW only upgrade kit2025-03-06
00195278690401VersanaPremier LOTUS 4PP2024-11-20
00195278690418VersanaPremier LOTUS 5PP2024-11-20
00195278722430LOGIQLOGIQ F R32024-11-20
00195278690388VersanaPremier R3 VS2024-10-28
00195278690395VersanaPremier R3 VA2024-10-28
00195278466471NAL4-20t-DH48062AG2024-05-30
00195278674197LOGIQe TP2023-12-20
00195278674203LOGIQe TB2023-12-20
00195278300034VersanaBalance R2 VS2023-06-15
00195278300096VersanaBalance R2 VA2023-06-15
00195278503404VersanaEssential R2 VS2023-06-13
00195278503411VersanaEssential R2 VA2023-06-13

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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00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
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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
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYN2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYN2026-05-29