HexaMotion SDOS104-05

GUDID 17350005180055

The intended use of the device is to realize a multi-dimensional movement pattern, e.g. of the Delta4PT or the Delta4 Phantom+.

Scandidos AB

Multi-modality therapeutic radiation phantom, anthropomorphic

• Primary Device ID: 17350005180055
• NIH Device Record Key: bf806032-8de0-4dc1-8306-12d9ed65caac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HexaMotion
• Version Model Number: SDOS104-05
• Catalog Number: SDOS104-05
• Company DUNS: 507639297
• Company Name: Scandidos AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	17350005180055 [Primary]

FDA Product Code

• LHO: Instrument, Quality-Assurance, Radiologic

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: 2018-03-29
• Device Publish Date: 2016-09-25

Devices Manufactured by Scandidos AB

• 17350005180048 - Delta4 Phantom+ MR: 2019-05-02 The intended use of the device is • quality assurance of patient specific treatment delivery prior to the treatment in IMRT (i
• 17350005180086 - Delta4 Phantom+ MR: 2019-05-02 The intended use of the device is • quality assurance of patient specific treatment delivery prior to the treatment in IMRT (i
• 17350005180000 - Delta4 Phantom+: 2019-04-24 The intended use of the device is • quality assurance of patient specific treatment delivery prior to the treatment in IMRT (i
• 17350005180017 - Delta4 Phantom+: 2019-04-24 The intended use of the device is • quality assurance of patient specific treatment delivery prior to the treatment in IMRT (i
• 17350005180062 - Delta4 Discover: 2018-07-06 The intended use of the device is • quality assurance of patient specific treatment delivery during and before external radiot
• 17350005180079 - Delta4 Discover: 2018-07-06 The intended use of the device is • quality assurance of patient specific treatment delivery during and before external radiot
• 17350005180024 - Delta4 Phantom+: 2018-03-29 The intended use of the device is • quality assurance of patient specific treatment delivery prior to the treatment in IMRT (i
• 17350005180031 - Delta4 Phantom+: 2018-03-29 The intended use of the device is • quality assurance of patient specific treatment delivery prior to the treatment in IMRT (i