FDA.reportPublic FDA data

Voluson

Primary DI
00840682118477
Brand
Voluson
Company
GE Ultrasound Korea Ltd.
Model
S6 BT14 to BT15 UPG
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K141639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141639000VOLUSON S6, VOLUSON S8GE Healthcare2014-07-18IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682118477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682118477008406821184778406821184770840682118477

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)437-1171xx@xx.xx

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
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
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 W5946724-52025-12-05
00198953042793LOGIQE10s R55921403-52025-12-05
00840682146531LOGIQE10s2020-04-27
00195278910493VolusonPerformance 16H43532LS2025-06-04
00195278910509VolusonPerformance 18Performance 182025-06-04
00195278985606LOGIQE10s R4 to R5 UPG59738652024-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.IYO2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.IYN2026-06-23
00841517112646L15-4FUJIFILM SONOSITE, INC.IYO2026-06-23
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.IYN2026-06-22
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
00841517112639L12-3FUJIFILM SONOSITE, INC.IYO2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10