FDA.reportPublic FDA data

ZiFix Traverse

Primary DI
00841439114841
Brand
ZiFix Traverse
Company
MEDTEC, INC.
Model
RT-4558CB04
Catalog number
RT-4558CB04
Device description
ZiFix Traverse with ONEClamp
Published
2025-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical
JAICouch, Radiation Therapy, Powered
JAKSystem, X-Ray, Tomography, Computed
KPSSystem, Tomography, Computed, Emission
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LNHSystem, Nuclear Magnetic Resonance Imaging
OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
JAICouch, Radiation Therapy, PoweredRadiology2
JAKSystem, X-Ray, Tomography, ComputedRadiology2
KPSSystem, Tomography, Computed, EmissionRadiology2
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic ResonanceRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171133000Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesQfix2017-07-11IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841439114841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439114841008414391148418414391148410841439114841

GMDN Terms#

Term, Definition table
TermDefinition
Radiological whole-body positionerA device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 712-737-8688regulatory@cqmedical.com

Regulatory Flags#

DUNS number
103977526
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841439115114BioXmark112105902025-07-01
00841439109571Marker Placement NeedleMTNW887351MTNW8873512017-08-02
00841439109588Marker Placement NeedleMTNW887358MTNW8873582017-08-02
00841439109595Coupled™ Fiducial Marker KitMTNW887709MTNW8877092017-08-02
00841439109601Coupled™ Fiducial Marker KitMTNW887710MTNW8877102017-08-02
00841439109618Coupled™ Fiducial Marker KitMTNW887711MTNW8877112017-08-02
00841439109625Coupled™ Fiducial Marker KitMTNW887712MTNW8877122017-08-02
00841439109632Fiducial MarkersMTNW887805MTNW8878052017-08-02
00841439109649Fiducial MarkersMTNW887808MTNW8878082017-08-02
00841439109656Fiducial MarkersMTNW887809MTNW8878092017-08-02
00841439109663Fiducial Marker KitMTNW887810MTNW8878102017-08-02
00841439109670Fiducial MarkersMTNW887812MTNW8878122017-08-02
00841439109687Fiducial MarkersMTNW887814MTNW8878142017-08-02
00841439109694Fiducial Marker KitMTNW887825MTNW8878252017-08-02
00841439109700Fiducial Marker KitMTNW887830MTNW8878302017-08-02
00841439109717Fiducial Marker KitMTNW887835MTNW8878352017-08-02
00841439109724Fiducial Marker KitMTNW887836MTNW8878362017-08-02
00841439109731Fiducial Marker KitMTNW887837MTNW8878372017-08-02
00841439109748Fiducial Marker KitMTNW887840MTNW8878402017-08-02
00841439109755Fiducial Marker KitMTNW887851MTNW8878512017-08-02

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Primary DI, Brand, Company table
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