DigiView

GUDID 00857050006007

Doctors Review Station - System, Image processing, Radiological

Digisonics Inc

Radiology PACS software

• Primary Device ID: 00857050006007
• NIH Device Record Key: 2181607b-52e5-4963-99f3-b9a273753b17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DigiView
• Version Model Number: 3.8
• Company DUNS: 099807927
• Company Name: Digisonics 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: 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	00857050006007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970402

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-27
• Device Publish Date: 2020-07-17

On-Brand Devices [DigiView]

• 00857050006007: Doctors Review Station - System, Image processing, Radiological
• 00857050006038: Doctor's Reading Station