GammaPod™

Basic Information

• Brand Name: GammaPod™
• Primary DI: 00850002615005
• Version / Model: Model A
• Catalog Number: XMSGP030A00-0.02
• Company Name: XCISION MEDICAL SYSTEMS, LLC
• Labeler DUNS: 788286941
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-01
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: c49ae7b9-e91e-468c-bf0e-0f91e47a9c5f

Device Description

Stereotactic Radiotherapy System

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: Yes
• Has Lot/Batch Number: No
• 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
IWB	System, Radiation Therapy, Radionuclide	Radiology	892.5750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38298	Stereotactic radiosurgical system	An assembly of devices designed to deliver a therapeutic radiation dose to an anatomical region from external beams produced from multiple radionuclide sources arranged in a fixed focal point collimated array; typically used to treat brain, neck, breast and spinal tumours. It typically consists of: 1) a stereotactic positioning device attached to the patient to define the three-dimensional (3-D) co-ordinates of the treatment site; 2) fixed diameter collimators; 3) high-density beam blockers; 4) a shielded housing to hold the sources, reducing room radiation; 5) a precision aligned array to cause the source beams to intersect at a single point; and 6) a moveable patient table.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850002615005	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180571	000