Delta4 Discover SDOS105-01 (Varian)

GUDID 17350005180062

The intended use of the device is • quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, includ

Scandidos AB

Accelerator system quality assurance device

• Primary Device ID: 17350005180062
• NIH Device Record Key: 181a180f-c239-47fe-9373-08257cd53a80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta4 Discover
• Version Model Number: SDOS105-01
• Catalog Number: SDOS105-01 (Varian)
• Company DUNS: 507639297
• Company Name: Scandidos AB
• 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: true
• 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

Customer Support Contacts

• Phone: +46184723030
• Email: info@scandidos.com
• Phone: +46184723030
• Email: info@scandidos.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	17350005180062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151426

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2016-09-25

On-Brand Devices [Delta4 Discover]

• 17350005180079: The intended use of the device is • quality assurance of patient specific treatment delivery d
• 17350005180062: The intended use of the device is • quality assurance of patient specific treatment delivery d