ProKnow DS

GUDID 00860000358705

ProKnow DS is a cloud-based RT-PACS to archive, inspect, analyze, and interact with radiation therapy patient data for retrospective studies, prospective analysis, and clinical decision support.

PROKNOW, LLC

Radiology PACS software

• Primary Device ID: 00860000358705
• NIH Device Record Key: 7a6e089c-61f8-4871-a959-d83026ff7788
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProKnow DS
• Version Model Number: 1.0
• Company DUNS: 081092366
• Company Name: PROKNOW, LLC
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000358705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182855

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: 2
• Public Version Date: 2019-05-23
• Device Publish Date: 2019-04-01