FDA.reportPublic FDA data

NA

Primary DI
00840682115681
Brand
NA
Company
GE Vingmed Ultrasound A/S
Model
6VT-D KN100110
Device description
6VT-D
Published
2016-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K131514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131514000GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMGe Vingmed Ultrasound AS2013-07-12IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682115681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682115681008406821156818406821156810840682115681

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal ultrasound imaging transducer, reusableAn ultrasound imaging transducer assembly enclosed in a fluid-resistant, acoustically- and electrically-insulated housing, designed to be inserted and positioned in the oesophagus to obtain ultrasound images of the heart and/or to navigate devices requiring ultrasound guidance and placement (e.g., endoscopy equipment or needle biopsy equipment). Also known as an oesophageal endosonography probe or transducer, it is composed of either a single transducer element or an array of transducer elements, i.e., piezoelectric element(s), active element(s), or crystal(s), and associated damping, backing, and matching layer materials. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
518870571
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953200421EchoPACSoftware Only v2112026-10-07
00198953200438EchoPACPlug-In v2112026-10-07
00195278951700EchoPACSoftware Only v2102025-08-08
00195278951717EchoPACPlug-In v2102025-08-08
00198953126073VividFocusTC0010112026-09-21
00198953172384VividExplorer2026-09-21
00198953172551VividAdvancedTC0010122026-09-21
00195278875860VscanAir CL2025-07-04
00195278504302EchoPACSoftware Only v2062022-08-23
00195278504326EchoPACPlug-in v2062022-08-23
00195278388483NA9VT-DKN1001302022-07-29
00195278435743VividE v204 4D ICE UPG2021-06-24
00198953157145Vscan AirR3.2 for Android2026-05-11
00198953157152Vscan AirR3.2 for iOS2026-05-11
00840682146647VividE80 v204 with OLED2020-08-12
00840682146661VividE80 v204 with LCD2020-08-12
00840682146678VividE90 v204 with OLED2020-08-12
00840682146692VividE90 v204 with LCD2020-08-12
00198953079249VscanAir R3.1 for Android2025-11-17
00198953079256VscanAir R3.1 for iOS2025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.IYN2026-10-26
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.ITX2026-10-26
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.IYO2026-10-26
07070554100863Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100870Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100887Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100894Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100900Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
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.IYO2026-09-30
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.IYO2026-09-30