FDA.reportPublic FDA data

NA

Primary DI
00195278466471
Brand
NA
Company
GE Medical Systems (China) Co.,Ltd.
Model
L4-20t-D
Catalog number
H48062AG
Device description
L4-20t-D
Published
2024-05-30
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
ITOTWISTER, BRACE SETTING
ITXTransducer, ultrasonic, diagnostic
IYNSystem, imaging, pulsed doppler, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITOTwister, Brace SettingPhysical Medicine1
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278466471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278466471001952784664711952784664710195278466471

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 Celsius60 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)437-1171xx@xx.xx

Regulatory Flags#

DUNS number
654658731
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953078716LOGIQe S2026-06-10
00198953078747LOGIQe X TP2026-06-10
00198953078754LOGIQe X TB2026-06-10
00198953147009LOGIQe X TBU2026-06-10
00198953147016LOGIQe X TPU2026-06-10
00198953147351LOGIQe R10 UPG2026-06-10
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
00195278674197LOGIQe TP2023-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYN2026-07-24
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGITX2026-07-24
04987670106088CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-07-24
00841436122061Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125444CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125833Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125857Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126045Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126656Multi-Purpose Workstation ™ StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126663CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112011iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYN2026-07-10
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYN2026-06-24