Voluson

GUDID 00840682118484

GE Ultrasound Korea Ltd.

General-purpose ultrasound imaging system
Primary Device ID00840682118484
NIH Device Record Key47fce1f0-15c6-4371-bc42-dcdaab2d35ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameVoluson
Version Model NumberP8 BT14 to BT15 UPG
Company DUNS690168810
Company NameGE Ultrasound Korea Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)437-1171
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682118484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-08-01

On-Brand Devices [Voluson]

00840682104166P8 BT16
00840682143820S8t BT18
00840682138239S10 Expert BT18
00840682138215S10 BT18
00840682138208P6 BT18
00840682138192P8 BT18
00840682138185S8 BT18
00840682122009S8 BT11 to BT12 UPG
00840682121996S6 BT11 to BT12 UPG
00840682118545S6 BT12 to BT14 UPG
00840682118538S8 BT14 to BT15 UPG
00840682118514S8 BT12 to BT14 UPG
00840682118507P8 BT13 to BT14 UPG
00840682118484P8 BT14 to BT15 UPG
00840682118477S6 BT14 to BT15 UPG
00840682108256S8 Pro BT16
00840682104326P6 BT16
00840682104319S6 BT16
00840682104241S8 BT16
00840682104234S10 BT16
00195278006837VOLUSON SWIFT CONSOLE ASSY
00195278006820VOLUSON SWIFT+ CONSOLE ASSY
00195278473103Voluson P8 BT22
00195278473097Voluson P6 BT22
00195278473080Voluson S6 BT22
00195278473073Voluson S8 BT22
00195278473066Voluson S8t BT22
00195278473059Voluson S10 BT22
00195278473042Voluson S10 Expert BT22
00195278473028Voluson Signature to BT22 UPG
00195278473011Voluson Performance to BT22 UPG
00195278560155Voluson SWIFT+ BT23
00195278560148Voluson SWIFT BT23
00195278560124Voluson SWIFT to BT23 UPG
00195278633811VOLUSON SIGNATURE 18
00195278633804VOLUSON SIGNATURE 20

Trademark Results [Voluson]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VOLUSON
VOLUSON
74049572 1687722 Live/Registered
KRETZTECHNIK AKTIENGESELLSCHAFT
1990-04-16

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