SDX System SDX306SE

GUDID 03760290230187

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.

DYN'R

Real-time position management respiratory gating system, spirometry

• Primary Device ID: 03760290230187
• NIH Device Record Key: 595b266b-f305-4f8c-b3fe-f72334b1ce71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SDX System
• Version Model Number: 3.0- Special Edition
• Catalog Number: SDX306SE
• Company DUNS: 380807099
• Company Name: DYN'R
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760290230019 [Previous]
GS1	03760290230170 [Primary]
GS1	03760290230187 [Package]; Contains: 03760290230170; Package: case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121845

FDA Product Code

• LHN: System, Radiation Therapy, Charged-Particle, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-02
• Device Publish Date: 2026-02-20