Box for ExamVue DR(outside 265mmx185mmx150mm)

GUDID 08809413810488

The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.

JPI HEALTHCARE. CO., LTD.

Basic diagnostic x-ray system application software
Primary Device ID08809413810488
NIH Device Record Key6ca8e00f-cca7-41f6-8e71-17226e02a924
Commercial Distribution StatusIn Commercial Distribution
Brand NameBox for ExamVue DR(outside 265mmx185mmx150mm)
Version Model NumberExamVue DR
Company DUNS687797852
Company NameJPI HEALTHCARE. CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone516 513-1330
Emailcust.serv@jpihealthcare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809413810488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, X-Ray, Stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-20
Device Publish Date2020-04-10

Devices Manufactured by JPI HEALTHCARE. CO., LTD.

08809413810679 - ExamVue 2023-06-23 ExamVue Duo is a software program designed to provide image acquisition, processing and operational management functions for dig
08809413810471 - Box for ExamVue PACS(outside 265mmx185mmx150mm)2020-04-20 The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consis
08809413810488 - Box for ExamVue DR(outside 265mmx185mmx150mm)2020-04-20The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.
08809413810488 - Box for ExamVue DR(outside 265mmx185mmx150mm)2020-04-20 The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray image
08809413810464 - Radiographic Grid2020-04-14 A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging or mammography. It typi
08809413810204 - Radiographic grid2020-03-04 A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging. It typically consists
08809413810211 - Radiographic Grid 2020-03-04 A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging or mammography. It typi
08809413810266 - Box for radiographic Grid-1000(9"x11"(outside 345mmx329mm))2020-03-04 A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging. It typically consists
08809413810273 - Box for radiographic Grid-1000(11"x13"(outside 395mmx380mm))2020-03-04 A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging. It typically consists

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