3D Bolus Application

Basic Information

• Brand Name: 3D Bolus Application
• Primary DI: 00860007402319
• Version / Model: v2021.1.0
• Company Name: Adaptiiv Medical Technologies Inc
• Labeler DUNS: 203502513
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-28
• Public Version: 1
• Public Version Date: 2022-04-05
• Public Version Status: New
• Public Device Record Key: 92a0703b-bcd7-44d8-894d-43b68ea9cd03

Device Description

3D Bolus Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy. The use of 3D Bolus application is by prescription only.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40887	Radiation therapy software	An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007402319	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]