FDA.reportPublic FDA data

Smart-V-Link

Primary DI
00894912002777
Brand
Smart-V-Link
Company
KOVEN TECHNOLOGY, INC.
Model
Smart-V-Link
Catalog number
Smart-V-Link
Device description
Vascular documentation software
Published
2016-02-25
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
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963274000V-LINK 3.2 FOR WINDOWSKoven Technology, Inc.1996-10-31IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894912002777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894912002777008949120027778949120027770894912002777

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system application software"An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and ""version"" or ""upgrade"" number."

Contacts#

Phone, Email table
PhoneEmail
314-542-2101info@koven.com

Regulatory Flags#

DUNS number
069261402
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894912002173ES102EXES102EXES102EX2016-02-24
00894912002180DVM 4500DVM 4500DVM 45002016-03-10
00894912002302BT10M5S8ABT10M5S8ABT10M5S8A2016-03-10
00894912002319BT10M5S8CBT10M5S8CBT10M5S8C2016-03-10
00894912002333BT5M05S8ABT5M05S8ABT5M05S8A2016-03-10
00894912002340BT5M05S8CBT5M05S8CBT5M05S8C2016-03-10
00894912002357BT8M05S8ABT8M05S8ABT8M05S8A2016-03-09
00894912002364BT8M05S8CBT8M05S8CBT8M05S8C2016-03-10
00894912002425T10M5S8CT10M5S8CT10M5S8C2016-03-10
00894912002449T5M05S8CT5M05S8CT5M05S8C2016-03-10
00894912002456T8M05S8CT8M05S8CT8M05S8C2016-03-10
00894912002975BT5M05S8ABT5M05S8ABT5M05S8A2016-07-06
00894912002432T2M20S8CT2M20S8CT2M20S8C2016-03-10
00894912002463T2M25N8AT2M25N8AT2M25N8A2016-03-10
00894912002876Pencil probeBP5M05S8ABP5M05S8A2016-06-29
00894912002890Pencil probeBP10M5S8ABP10M5S8A2016-06-29
00894912002883Pencil probeBP8M05S8ABP8M05S8A2018-04-10
00894912002036CTCT-4CT-42020-04-03
00894912002326BT2M20S8CBT2M20S8CBT2M20S8C2016-03-10
00894912002067PAUS2.0PAUS2.02025-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYO2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYO2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290031522HERA Z20e Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08800290041705miniER7SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041934LA2-9SSAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041941CMV1-10SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042184PA1-5ASAMSUNG MEDISON CO., LTD.IYO2025-12-05