VidiStar PACS & DICOM Viewer Software

GUDID 00869047000431

The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet.

HITACHI HEALTHCARE AMERICAS CORPORATION

Radiology PACS software
Primary Device ID00869047000431
NIH Device Record Keyf017040c-95b4-4429-9193-d5559290269b
Commercial Distribution StatusIn Commercial Distribution
Brand NameVidiStar PACS & DICOM Viewer Software
Version Model Number4.X.X
Company DUNS603156043
Company NameHITACHI HEALTHCARE AMERICAS CORPORATION
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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100869047000431 [Primary]

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-23
Device Publish Date2018-09-27

Devices Manufactured by HITACHI HEALTHCARE AMERICAS CORPORATION

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00860007188329 - UST-91502021-07-09 Ultrasound Laparoscopic Probe
00860007188336 - UST-52114P-B2021-07-09 Ultrasound Brainpath Probe
00869047000455 - D&K Technologies2021-02-23 System Arm, Stabilizer, Stepper & Stand
00869047000462 - D&K Technologies2021-02-23 System Arm, Stabilizer, Stepper & Stand
00869047000448 - HITACHI HEALTHCARE AMERICAS2020-07-07 Ultrasound transducer
00869047000431 - VidiStar PACS & DICOM Viewer Software2019-05-23The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet.
00869047000431 - VidiStar PACS & DICOM Viewer Software2019-05-23 The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as
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