FDA.reportPublic FDA data

SDX System

Primary DI
03760290230187
Brand
SDX System
Company
DYN'R
Model
3.0- Special Edition
Catalog number
SDX306SE
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.
Published
2026-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHNSystem, Radiation Therapy, Charged-Particle, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121845000SDX SYSTEMDyn'R Sas2012-10-19IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760290230187PackageGS11In Commercial Distribution
03760290230019PreviousGS10
03760290230170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760290230187037602902301873760290230187
03760290230019037602902300193760290230019
03760290230170037602902301703760290230170

GMDN Terms#

Term, Definition table
TermDefinition
Real-time position management respiratory gating system, spirometryAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33442210734dynr@dynr.com

Regulatory Flags#

DUNS number
380807099
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760290230170SDX System3.0- Special Edition SDX306SE2026-02-20
03760290230019SDX System3.0SDX0350V3.02018-10-30
03760290230026SDX System3.0SDX0340V3.02018-10-30
03760290230101SDX SystemV2.0SDX0359V2.02018-10-30
03760290230118SDX SystemV1.0SDX0360V1.02018-10-30
03760290230125SDX System V1.0SDX0365V1.02018-10-30
03760290230132SDX SystemV1.0SDX0361V1.02018-10-30
03615070000101SDX System2.103502017-02-02
03615070000200SDX System1.003402017-02-02
03615070000507SDX System3.0SDX0350V3.02017-07-25
03615070000606SDX System3.0SDX0340V3.02017-07-25
03615070000705SDX SystemV2.0SDX0359V2.02017-09-20
03615070000804SDX SystemV1.0SDX0360V1.02017-09-20
03615070000903SDX System1.0SDX0365V1.02017-05-02
03615070000408SDX System1.0SDX0361V1.02017-05-02
03760290230149SDX SystemV1.0SDX0366V1.02018-10-02
03760290230156SDX SystemV1.0SDX0367V1.02022-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864366000148MEVION S250-FIT Proton Therapy SystemMEVION MEDICAL SYSTEMS, INC.LHN2026-05-04
00864366000117MEVION S250-FIT Proton Therapy SystemMEVION MEDICAL SYSTEMS, INC.LHN2026-04-30
00858991006194ProBeam 360 Proton Therapy System - Rotating GantryVarian Medical Systems Particle Therapy GmbH & Co. KGLHN2026-04-29
EPTWTM310220PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-15
EPTWTN310220PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-15
EPTWTW310220PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-15
EPTWTM310240SemiflexPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTM310250PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTN310240SemiflexPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTN310250PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTW310240SemiflexPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTW310250PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
04560333350334PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350341PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350358PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350365PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350372PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350389PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350396PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350402PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350419PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350426PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350433PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350440PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350457PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350464PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
03760290230170SDX SystemDYN'RLHN2026-02-20
04560333350280PROBEATHITACHI, LTD.LHN2026-01-20
00841962120456Alta for HexaPODQfixLHN2026-01-14
00841962120388Lumen AirShuttleQfixLHN2025-12-02