SciMoCa

GUDID 00863284000315

SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.

RADIALOGICA LLC

Radiation therapy software

• Primary Device ID: 00863284000315
• NIH Device Record Key: 1b9b0ca6-f8e7-4f64-a2d1-62c144257471
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciMoCa
• Version Model Number: 1.x
• Company DUNS: 968999610
• Company Name: RADIALOGICA LLC
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: (800) 515-9132
• Email: support@radialogica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863284000315 [Primary]

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: 2018-05-07
• Device Publish Date: 2018-04-06

Devices Manufactured by RADIALOGICA LLC

• 00863284000308 - fullAccess: 2019-10-07 A fully-integrated data display, communication and analysis software platform that enables users to access, analyze and share di
• 00863284000315 - SciMoCa: 2018-05-07SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
• 00863284000315 - SciMoCa: 2018-05-07 SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose ge