FDA.reportPublic FDA data

VOLUSON

Primary DI
00840682122009
Brand
VOLUSON
Company
GE Ultrasound Korea Ltd.
Model
S8 BT11 to BT12 UPG
Device description
BT12 Software Upgrade Kit for VS8
Published
2016-10-14
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682122009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682122009008406821220098406821220090840682122009

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
true
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841517112035iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
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00841517112462iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
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00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYN2026-07-10
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.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24