FDA.reportPublic FDA data

UltraVision

Primary DI
B616UVTKHL1840
Brand
UltraVision
Company
ULTRAVISION CORPORATION
Model
Konica Hockey Stick Linear 18-4
Catalog number
n/a
Device description
Linear Ultrasonic Transducer
Published
2022-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173265000UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation2017-11-07IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B616UVTKHL1840PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
561-626-4055info@UltraVisionUSA.com

Regulatory Flags#

DUNS number
080218827
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B616UVTKCC520UltraVisionKonica Curved Probe C5-2n/a2022-08-19
B616UVTKL1440UltraVisionKonica Linear Probe L14-4n/a2022-08-19
B616UVXC0UltraVisionXC2022-08-16
B616UVXP0UltraVisionXP2020-11-20
B616UVXR0UltraVisionXR2020-11-20
B616UVXS0UltraVisionXS2020-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
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08056304455437MyLabA50ESAOTE SPAITX2025-07-07
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08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
04719890960269Neo MedicalAco Healthcare Co., Ltd.ITX2024-09-09
00850055427075HYDROS TRUS ProbePROCEPT BioRobotics CorporationITX2024-09-06
04068151012477ACUSON Origin ICE Diagnostic Ultrasound SystemSIEMENS MEDICAL SOLUTIONS USA, INC.ITX2024-08-22
04719890960061Aco SmartcareAco Healthcare Co., Ltd.ITX2024-05-13
08056304455628MyLabE80ESAOTE SPAITX2024-03-29