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

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• Primary Device ID: 00869047000431
• NIH Device Record Key: f017040c-95b4-4429-9193-d5559290269b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VidiStar PACS & DICOM Viewer Software
• Version Model Number: 4.X.X
• Company DUNS: 603156043
• Company Name: HITACHI HEALTHCARE AMERICAS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869047000431 [Primary]

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-23
• Device Publish Date: 2018-09-27

Devices Manufactured by HITACHI HEALTHCARE AMERICAS CORPORATION

• 00860007188305 - C9150LA: 2021-07-09 4-way Laparoscopic Ultrasound Transducer/Smart Connector
• 00860007188312 - UST 5550-R: 2021-07-09 Ultrasound Robotic Probe
• 00860007188329 - UST-9150: 2021-07-09 Ultrasound Laparoscopic Probe
• 00860007188336 - UST-52114P-B: 2021-07-09 Ultrasound Brainpath Probe
• 00869047000455 - D&K Technologies: 2021-02-23 System Arm, Stabilizer, Stepper & Stand
• 00869047000462 - D&K Technologies: 2021-02-23 System Arm, Stabilizer, Stepper & Stand
• 00869047000448 - HITACHI HEALTHCARE AMERICAS: 2020-07-07 Ultrasound transducer
• 00869047000431 - VidiStar PACS & DICOM Viewer Software: 2019-05-23The 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 Software: 2019-05-23 The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as