FDA.reportPublic FDA data

DYN'R

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30151968423015196842DYN'R US Inc.1Y2026-01-013363 Ne 163rd St Ste 806e Miami FL US 33160

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
03760290230019SDX System - SDX Module+33442210734dynr@dynr.com
03760290230026SDX System - SDX Trolley+33442210734dynr@dynr.com
03760290230101SDX System - Gating Module for Varian C-Series+33442210734dynr@dynr.com
03760290230118SDX System - Gating Module for IBA ProteusPlus+3342210734dynr@dynr.com
03760290230125SDX System - Gating Module for Probeam+33442210734dynr@dynr.com
03760290230132SDX System - Gating Module for Siemens 4D-CT+33442210734dynr@dynr.com
03760290230170SDX System - 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.+33442210734dynr@dynr.com
03760290230187SDX System - 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.+33442210734dynr@dynr.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2269621000785779K121845SDX SYSTEMIYE2012-10-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE12012-10-19

PMN#

GUDID#

SDX System - 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

2026-02-20

SDX System - 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

2026-02-20