EPIgray 2.0.6

GUDID B501EPIGRAY020006

Radiotherapy software quality assurance tool.

DOSISOFT

Radiation therapy software

• Primary Device ID: B501EPIGRAY020006
• NIH Device Record Key: aaf290f1-258a-4b41-9ab0-7bbecb716bef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIgray
• Version Model Number: 2.0.6
• Catalog Number: 2.0.6
• Company DUNS: 264815932
• Company Name: DOSISOFT
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B501EPIGRAY020006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112723

FDA Product Code

• MUJ: System,Planning,Radiation Therapy Treatment

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-10

On-Brand Devices [EPIgray]

• B501EPIGRAY020006: Radiotherapy software quality assurance tool.
• B501EPIGRAY020010: Radiotherapy quality assurance software tool.