FDA.reportPublic FDA data

N/A

Primary DI
00195278644152
Brand
N/A
Company
GE Medical Systems (China) Co.,Ltd.
Model
RAB7-D
Catalog number
H48062AN
Device description
RAB7-D
Published
2025-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242168000Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics2024-12-20IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278644152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278644152001952786441521952786441520195278644152

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

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
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
00840682190299NAL4-20t-RSH48062AJ2021-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027419LA2-9SDSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290028638CA2-8ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029390EV2-10ASAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029420CV1-8AESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.ITX2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08800289979132cV4 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
08800289970351cV8 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-02-27