Delta4 Phantom+ SDOS101-20

GUDID 17350005180000

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 Multi-modality therapeutic radiation phantom, anthropomorphic

• Primary Device ID: 17350005180000
• NIH Device Record Key: cfc32c34-2797-4bdf-b912-f46a81348310
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta4 Phantom+
• Version Model Number: PMMA
• Catalog Number: SDOS101-20
• Company DUNS: 507639297
• Company Name: Scandidos AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	17350005180000 [Primary]

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: 2019-04-24
• Device Publish Date: 2016-09-25

On-Brand Devices [Delta4 Phantom+]

• 17350005180031: The intended use of the device is • quality assurance of patient specific treatment delivery p
• 17350005180024: The intended use of the device is • quality assurance of patient specific treatment delivery p
• 17350005180017: The intended use of the device is • quality assurance of patient specific treatment delivery p
• 17350005180000: The intended use of the device is • quality assurance of patient specific treatment delivery p