FDA.reportPublic FDA data

Voluson

Primary DI
00195278910509
Brand
Voluson
Company
GE Ultrasound Korea Ltd.
Model
Performance 18
Catalog number
H43532LR
Device description
Voluson Performance 18
Published
2025-06-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
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
K250543000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250543000Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics2025-05-29IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278910509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278910509001952789105091952789105090195278910509

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 Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

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
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
00195278111265LOGIQP10 R42021-02-17

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