True 3D Viewer SW-0001-1601

GUDID 00851325007003

Software: The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.

ECHOPIXEL, INC.

Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation

• Primary Device ID: 00851325007003
• NIH Device Record Key: 6ee5e3ec-c828-4b7f-8058-c17371f5f31c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: True 3D Viewer
• Version Model Number: EP-00003
• Catalog Number: SW-0001-1601
• Company DUNS: 079890297
• Company Name: ECHOPIXEL, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com
• Phone: 1-844-273-7766
• Email: salesops@echopixeltech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851325007003 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-10-11