FDA.reportPublic FDA data

JointVue 3D Echo

Primary DI
00850014885007
Brand
JointVue 3D Echo
Company
JOINTVUE, LLC
Model
1.0
Device description
3D Echo Software
Published
2020-01-31
Public version status
Update
Distribution status
Not 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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1725130003D EchoJointvue, LLC2017-09-14LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014885007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014885007008500148850078500148850070850014885007

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system operation softwareMainframe or personal computer (PC) based operating system software (or firmware) specific to the central processing unit (CPU) incorporated into a diagnostic ultrasound system configuration. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a "version number" are commonly used identify different operating system versions.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8652351241customercare@jointvue.com

Regulatory Flags#

DUNS number
117090348
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014885021JointVue jFit1.02020-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYO2026-09-21
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953113493LOGIQGE Ultrasound Korea Ltd.IYO2026-01-21
00198953042731LOGIQGE Ultrasound Korea Ltd.IYO2025-12-05
00198953042748LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00198953042755LOGIQGE Ultrasound Korea Ltd.IYO2025-12-05
00198953042762LOGIQGE Ultrasound Korea Ltd.IYO2025-12-05
00198953042779LOGIQGE Ultrasound Korea Ltd.IYO2025-12-05
00198953042793LOGIQGE Ultrasound Korea Ltd.IYO2025-12-05
00198953042816LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00198953001400VenueGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-11-17
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10