FDA.reportPublic FDA data

NA

Primary DI
00840682115650
Brand
NA
Company
GE Vingmed Ultrasound A/S
Model
6VT-D
Catalog number
KN100120
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
K141093000
K142323000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1410930006VT-D ULTRASOUND TRANSDUCERGe Vingmed Ultrasound AS2014-05-15ITX
K142323000Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel , Ltd.2014-10-10IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682115650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682115650008406821156508406821156500840682115650

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
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00840682146661VividE80 v204 with LCD2020-08-12
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00195278951700EchoPACSoftware Only v2102025-08-08
00195278951717EchoPACPlug-In v2102025-08-08
00195278916938VividPioneer v2102025-08-07
00195278884725VscanAir R3 for Android2025-05-22
00195278884749VscanAir R3 for iOS2025-05-22
00195278640550VscanAir R2 for iOS2023-09-26
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00195278640574VscanAir R2 CL2023-09-26
00195278660701VscanAir SL2023-09-26
00195278505330VividE95 v2062022-09-20
00195278504302EchoPACSoftware Only v2062022-08-23

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