FDA.reportPublic FDA data

LOGIQ

Primary DI
00198953078747
Brand
LOGIQ
Company
GE Medical Systems (China) Co.,Ltd.
Model
e X TP
Device description
LOGIQ e X TP Consol
Published
2026-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYXCamera, Scintillation (Gamma)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
IYXCamera, Scintillation (Gamma)Radiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260398000LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics2026-05-26IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953078747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953078747001989530787471989530787470198953078747

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 Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
654658731
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953078716LOGIQe S2026-06-10
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
00195278466471NAL4-20t-DH48062AG2024-05-30
00195278674197LOGIQe TP2023-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYN2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.IYO2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.IYN2026-06-23
00841517112646L15-4FUJIFILM SONOSITE, INC.IYO2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.IYO2026-06-22
00841517112639L12-3FUJIFILM SONOSITE, INC.IYN2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
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