SDX System

Basic Information

• Brand Name: SDX System
• Primary DI: 03615070000804
• Version / Model: V1.0
• Catalog Number: SDX0360V1.0
• Company Name: DYN'R
• Labeler DUNS: 380807099
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-20
• Public Version: 5
• Public Version Date: 2018-12-31
• Public Version Status: Update
• Public Device Record Key: 0358c002-bb3e-4025-ac8c-3d603ff10cb0
• Distribution End Date: 2018-12-31

Device Description

Gating Module for IBA Proteus Plus

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
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	892.5050	2
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62723	Real-time position management respiratory gating system, spirometry	An assembly of electronic devices designed to track the respiratory pattern of a patient by means of spirometry to correlate tumour position with the respiratory cycle during radiation treatment planning, radiotherapy, computed tomography (CT) imaging, or other radiation procedures. It tracks the patient’s respiration using a spirometer into which the patient breaths, providing real-time measurement of the respiratory cycle to enable irradiation control during the procedure, and may include visual feedback enabling the patient to manage their own voluntary breathing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03615070000804	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121845	000