FDA.reportPublic FDA data

ZiFix™

Primary DI
10841962110508
Brand
ZiFix™
Company
Qfix
Model
RT-4558CB02
Catalog number
RT-4558CB02
Device description
ZiFix™ Abdominal/Thoracic Motion Control System
Published
2017-07-17
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841962110508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084196211050810841962110508

GMDN Terms#

Term, Definition table
TermDefinition
Indexed-immobilization patient positioning systemA assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (indexing) points on the table. It is used to ensure both adequate positioning and immobilization of a patient and to help ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams or fields used in radiation therapy treatments, diagnostic imaging studies. It may accommodate a variety of anatomically targeted patient positioning and immobilization attachments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length130Centimeter
Length170Centimeter
Width13Centimeter
Width20Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
610-268-0585Compliance@qfix.com

Regulatory Flags#

DUNS number
808875397
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841439115305MultiFix 2RT-5411RT-54112026-06-04
00841439115312MultiFix 2 - JointGlowRT-5412RT-54122026-06-04
00841439115329Extremity RiserRT-5413RT-54132026-06-04
00841439115336Extremity Riser - JointGlowRT-5414RT-54142026-06-04
00841439115343MultiFix Indexing PostRT-5415RT-54152026-06-04
00841962120500Single Hand Extremity FibreplastRT-E778KPR2HRT-E778KPR2H2026-06-05
00841962120517Knee / Elbow Extremity FibreplastRT-E778KPR2NERT-E778KPR2NE2026-06-05
00841962120524Foot Extremity FibreplastRT-E778KPR3FTRT-E778KPR3FT2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastRT-E778KPR3HSRT-E778KPR3HS2026-06-05
00841439115237Opti-TattUTRT-4100UTRT-41002026-05-29
00841439115244Opti-TattUTRT-4200UTRT-42002026-05-29
00841439115251Opti-TattUTRT-4300UTRT-43002026-05-29
00841962120562FibreplastRT-A182KYSDNRT-A182KYSDN2026-05-26
00841962120425Opti Handle Thermoplastic AdapterRT-4546-05RT-4546-052026-05-18
00841962120319Aquaplast PS™PS-1309CSSPS-1309CSS2025-07-09
10841962107447Aquaplast PS™PS-1307PS-13072016-09-13
10841962108307VacQfix™RT-4517-4079VF15RT-4517-4079VF152016-09-13
10841962109090QUANTUM™ CT OverlayRT-4550TE24RT-4550TE242016-09-13
10841962109274kVue™ EdgeRT-4551KVERT-4551KVE2016-09-13
10841962109403Stradivarius™RT-4558CB01RT-4558CB012016-09-13

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Primary DI, Brand, Company table
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