Delta4 Phantom+ MR SDOS101-36

GUDID 17350005180048

The intended use of the device is • quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking). • quality assurance of the radiation delivery system.

Scandidos AB

Multi-modality therapeutic radiation phantom, anthropomorphic

• Primary Device ID: 17350005180048
• NIH Device Record Key: 661e31b2-8698-484a-867e-47e8db7feb84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta4 Phantom+ MR
• Version Model Number: PMMA
• Catalog Number: SDOS101-36
• Company DUNS: 507639297
• Company Name: Scandidos AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	17350005180048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183606

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2019-05-02
• Device Publish Date: 2019-04-24

On-Brand Devices [Delta4 Phantom+ MR]

• 17350005180086: The intended use of the device is • quality assurance of patient specific treatment delivery p
• 17350005180048: The intended use of the device is • quality assurance of patient specific treatment delivery p