FDA.reportPublic FDA data

LOGIQ

Primary DI
00198953113493
Brand
LOGIQ
Company
GE Ultrasound Korea Ltd.
Model
Totus R5 SW upgrade
Catalog number
H46192BB
Device description
LOGIQ Totus R5 SW upgrade
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253370000LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics2026-01-08IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953113493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953113493001989531134931989531134930198953113493

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
690168810
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682110938LOGIQP92016-08-01
00840682118477VolusonS6 BT14 to BT15 UPG2016-08-01
00840682118484VolusonP8 BT14 to BT15 UPG2016-08-01
00840682118507VolusonP8 BT13 to BT14 UPG2016-08-01
00840682118514VolusonS8 BT12 to BT14 UPG2016-08-01
00840682118538VolusonS8 BT14 to BT15 UPG2016-08-01
00840682118545VolusonS6 BT12 to BT14 UPG2016-08-01
00840682121996VOLUSONS6 BT11 to BT12 UPG2016-10-14
00840682122009VOLUSONS8 BT11 to BT12 UPG2016-10-14
00198953121382VolusonSignature 20 BT272026-05-28
00198953113554LOGIQTotus R5H46152BC2026-01-26
00198953113516LOGIQLOGIQ Totus R5 HW and SW upgradeH46192BC2026-01-21
00198953113547LOGIQTotus R5 HDUH46152BD2026-01-21
00198953109403LOGIQFortis R5 LCD6601000-52026-01-14
00198953109410LOGIQFortis R5 HDU6602000-52026-01-14
00198953109427LOGIQFortis R3R4_R5 UPG HW Wireless5946728-52026-01-14
00198953109434LOGIQFortis R3R4_R5 UPG5946725-52026-01-14
00198953109458LOGIQFortis R3R4_R5 SW UPG Wireless5946727-52026-01-14
00198953109465LOGIQFortis R3R4_R5 UPG HW5946726-52026-01-14
00198953042731LOGIQE10s R3R4_R5 UPG HW5946722-52025-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04068151012453syngo.CT Coronary CockpitSiemens Healthcare GmbHQIH2026-07-17
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112011iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
04068151034202syngo DynamicsSiemens Healthineers AGQIH2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2026-07-10
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.IYO2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYO2026-06-24