SDX System

Basic Information

• Brand Name: SDX System
• Primary DI: 03760290230170
• Version / Model: 3.0- Special Edition
• Catalog Number: SDX306SE
• Company Name: DYN'R
• Labeler DUNS: 380807099
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-20
• Public Version: 1
• Public Version Date: 2026-03-02
• Public Version Status: New
• Public Device Record Key: 595b266b-f305-4f8c-b3fe-f72334b1ce71

Device Description

SDX Module: The SDX 3.0-SE (Special Edition) is new version of the SDX system 3.0 with a compact design: a standalone box housing all the necessary electronics, removing the need for the trolley.As the SDX system 3.0, The SDX system 3.0- Special Edition has the same intended use, the same technological characteristics , the same performances as that of the SDX system with automatic gating Module (primary predicate) and the SDX system 3.0. The SDX system 3.0-SE does not raise new questions of safety and effectiveness.

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
Package	03760290230187	GS1	case	1	In Commercial Distribution
Primary	03760290230170	GS1
Previous	03760290230019	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121845	000