FDA.reportPublic FDA data

LOGIQ

Primary DI
00195278835802
Brand
LOGIQ
Company
GE Ultrasound Korea Ltd.
Model
Fortis R3 to R4 HW Upgrade
Catalog number
5946726
Device description
LOGIQ Fortis R3 to R4 Upgrade with Hardware
Published
2024-03-04
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231989000LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,2023-11-07IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278835802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278835802001952788358021952788358020195278835802

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 Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690168810
Device count
1
Serial number
true
Manufacturing date on label
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
00198953113493LOGIQTotus R5 SW upgradeH46192BB2026-01-21
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841517112035iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
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00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
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00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYN2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2026-07-10
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
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00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24