FDA.reportPublic FDA data

LOGIQ

Primary DI
00195278464651
Brand
LOGIQ
Company
GE Ultrasound Korea Ltd.
Model
P9 R4 to R4.5 SW Conversion
Device description
LP8 R4 to R4.5 SW Conversion
Published
2022-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K214039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214039000LOGIQ P10, LOGIQ P9, LOGIQ P8GE Medical Systems Ultrasound and Primary Care Diagnostics2022-03-22IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278464651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278464651001952784646511952784646510195278464651

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.

Regulatory Flags#

DUNS number
690168810
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
false
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
00198953121382VolusonSignature 20 BT272026-05-28
00198953113493LOGIQTotus R5 SW upgradeH46192BB2026-01-21
00198953042731LOGIQE10s R3R4_R5 UPG HW5946722-52025-12-05
00198953042755LOGIQE10s R3R4_R5 UPG5946721-52025-12-05
00198953042762LOGIQE10s R3R4_R5 SW UPG Wireless5946723-52025-12-05
00198953042779LOGIQE10s R3R4_R5 UPG HW Wireless5946724-52025-12-05
00198953042793LOGIQE10s R55921403-52025-12-05
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018318051AI PlatformExo Imaging, Inc.IYN2026-10-22
03770033463055FETOLYDIAGNOLYIYO2026-10-22
03770033463055FETOLYDIAGNOLYIYN2026-10-22
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083246VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
06948941160022Bladder ScannerMeda Co., LtdITX2026-10-08
06948941160022Bladder ScannerMeda Co., LtdIYO2026-10-08
00855683006821AquaflexPARKER LABORATORIES INCIYO2026-10-01
00855683006845AquaflexPARKER LABORATORIES INCIYO2026-10-01
04719873009510"Esaote MyLabX1" Ultrasound Transducer_Linear ArrayQISDA CORPORATIONITX2026-10-01
04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550170EdgeFlow UH10CEdgeCare Inc.IYO2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.IYO2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYN2026-09-29
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYO2026-09-29
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationITX2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYN2026-09-24
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYO2026-09-21