PRONOVA SC360

Basic Information

• Brand Name: PRONOVA SC360
• Primary DI: 00863274000301
• Version / Model: R1.0
• Company Name: PRONOVA SOLUTIONS, LLC
• Labeler DUNS: 968714563
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-19
• Public Version: 3
• Public Version Date: 2018-10-10
• Public Version Status: Update
• Public Device Record Key: aaaedcc4-1118-4636-b684-f1f0cc0ab5e7

Device Description

Proton Therapy 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: No
• 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
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47069	Proton therapy system	An assembly of devices/sub-systems designed to produce and deliver a transverse- and longitudinal-dose proton beam to treat localized tumours and other conditions susceptible to treatment by radiation. It typically consists of components for beam production, transport and delivery; patient positioning; system and component control; and software. It will typically be configured to a particular site’s requirements.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00863274000301	GS1

Premarket Submissions

Submission Number	Supplement Number
K162246	000