3D Bolus Software

GUDID 00860007402302

3D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.

Adaptiiv Medical Technologies Inc

Radiation therapy software

• Primary Device ID: 00860007402302
• NIH Device Record Key: 1e70bcc2-f9ab-4e8a-adbf-e4291c76f0e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Bolus Software
• Version Model Number: v3.0.0
• Company DUNS: 203502513
• Company Name: Adaptiiv Medical Technologies Inc
• 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: 9024429091
• Email: support@adaptiiv.com
• Phone: 9024429091
• Email: support@adaptiiv.com
• Phone: 9024429091
• Email: support@adaptiiv.com
• Phone: 9024429091
• Email: support@adaptiiv.com
• Phone: 9024429091
• Email: support@adaptiiv.com
• Phone: 9024429091
• Email: support@adaptiiv.com
• Phone: 9024429091
• Email: support@adaptiiv.com
• Phone: 9024429091
• Email: support@adaptiiv.com
• Phone: 9024429091
• Email: support@adaptiiv.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007402302 [Primary]

FDA Product Code

• MUJ: System, Planning, Radiation Therapy Treatment

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: 2021-08-17
• Device Publish Date: 2021-08-09

Devices Manufactured by Adaptiiv Medical Technologies Inc

• 00860007402340 - TrueFlex Bolus: 2024-12-17 TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiati
• 00860007402371 - Nova Surface Applicator: 2024-12-17 Nova Surface Applicator is a 3D printed patient-matched radiation therapy accessory that expands the application of High Dose Ra
• 10860007402385 - TrueFit Bolus: 2024-12-17 TrueFit Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiatio
• 10860007402330 - Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU): 2022-08-24 Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customizable accessory that expands the application of
• 00860007402319 - 3D Bolus Application: 2022-04-05 3D Bolus Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning sy
• 00860007402326 - 3D Brachy Application: 2022-04-05 3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning s
• 00860007402302 - 3D Bolus Software: 2021-08-173D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.
• 00860007402302 - 3D Bolus Software: 2021-08-17 3D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS)