FDA.reportPublic FDA data

LOGIQ

Primary DI
00198953109434
Brand
LOGIQ
Company
GE Ultrasound Korea Ltd.
Model
Fortis R3R4_R5 UPG
Catalog number
5946725-5
Device description
LOGIQ Fortis R3R4 to R5 SW Upgrade
Published
2026-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K253366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253366000LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics2026-01-07IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953109434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953109434001989531094341989531094340198953109434

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
00195278910509VolusonPerformance 18H43532LR2025-06-04
00195278464613LOGIQP8 R4.52022-03-28
00195278464620LOGIQP10 R4 to R4.5 SW Conversion2022-03-28
00195278464637LOGIQP9 R4.52022-03-28
00195278464644LOGIQP10 R4.52022-03-28
00195278464651LOGIQP9 R4 to R4.5 SW Conversion2022-03-28
00195278464668LOGIQP10 R4.5 HD2022-03-28
00195278464675LOGIQP9 R4 to R4.5 SW Conversion2022-03-28
00195278487414LOGIQE10s R2 to R3 UPG2022-01-20
00195278473011VolusonPerformance to BT22 UPGVoluson-Performance-to-BT22-UPG2021-12-14
00195278473028VolusonSignature to BT22 UPGVoluson-Signature-to-BT22-UPG2021-12-14
00195278473042VolusonS10 Expert BT22VOLUSON-S10Expert-BT222021-12-14
00195278473059VolusonS10 T22VOLUSON-S10-BT222021-12-14
00195278473066VolusonS8t BT22VOLUSON-S8t-BT222021-12-14
00195278473073VolusonS8 BT22VOLUSON-S8-BT222021-12-14
00195278473080VolusonS6 BT22VOLUSON-S6-BT222021-12-14
00195278473097VolusonP6 BT22VOLUSON-P6-BT222021-12-14
00195278473103VolusonP8 BT22VOLUSON-P8-BT222021-12-14
00195278111241LOGIQP8 R42021-02-17
00195278111258LOGIQP9 R42021-02-17

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