FDA.reportPublic FDA data

SDX System

Primary DI
03615070000804
Brand
SDX System
Company
DYN'R
Model
V1.0
Catalog number
SDX0360V1.0
Device description
Gating Module for IBA Proteus Plus
Published
2017-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
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
03615070000804PreviousGS10
03760290230118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615070000804036150700008043615070000804
03760290230118037602902301183760290230118

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
+3342210734dynr@dynr.com
+33442210734dynr@dynr.com

Regulatory Flags#

DUNS number
380807099
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760290230170SDX System3.0- Special Edition SDX306SE2026-02-20
03760290230187SDX 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
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
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22
08720168162793DSPS-Prominent® Cradle-VIMACROMEDICS B.V.IYE2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.IYE2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.IYE2026-04-22
08720168163325DSPS-Prominent® Cradle-VIIMACROMEDICS B.V.IYE2026-04-22