FDA.reportPublic FDA data

VacQfix™

Primary DI
10841962108147
Brand
VacQfix™
Company
Qfix
Model
RT-4517-100150F70
Catalog number
RT-4517-100150F70
Device description
VacQfix Cushion, 100cm x 150cm 70L fill
Published
2016-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAICouch, radiation therapy, powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAICouch, Radiation Therapy, PoweredRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841962108147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084196210814710841962108147

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum-mould patient positioning systemAn assembly of devices designed to apply a vacuum to a cushion or bag filled with foam-like material that is placed under, on, or around a patients body parts. A vacuum is applied to the contents of the cushion forming a patient specific (custom-made) mould. The moulds can be whole body or selected body parts and help ensure adequate positioning and immobilization of the patient during diagnostic imaging and/or radiation therapy procedures facilitating reproducible positioning for serial procedures. This system typically includes reusable foam-filled bags, cushions, a vacuum unit, hardware, seals, and interfaces used to connect the mould to another patient positioning system (PPS).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length150Centimeter
Total Volume70Liter
Width100Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(610)268-0585Compliance@qfix.com

Regulatory Flags#

DUNS number
808875397
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10841962109441kVue™ Stradivarius™RT-4558KV1RT-4558KV12016-09-13
10841962108000SofTouch™RT-4464-1RT-4464-12016-09-13
10841962108130VacQfix™RT-4517100130PENF45MRT-4517100130PENF45M2016-09-13
10841962108161VacQfix™RT-4517-100220F120RT-4517-100220F1202016-09-13
10841962108055VacQfix™RT-4517-0003RT-4517-00032016-09-13
10841962119181VacQfix™RT-4517-70230F65FMRT-4517-70230F65FM2022-02-03
00841962120463Dexalign™ Hand Positioner RT-5401RT-54012026-04-28
00841962120470JointGlow™ Hand PositionerRT-5402RT-54022026-04-28
00841962120548Alpine Stirrups, Metric, LeftRT-5100-54L-CERT-5100-54L-CE2026-04-14
00841962120555Alpine Stirrups, Metric, RightRT-5100-54R-CERT-5100-54R-CE2026-04-14
10841962111093Thermoplastic Nasal SplintsTHERMTHERM2021-01-12
10841962100851Aquaplast RT™RT-1883P3RT-1883P32016-12-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841962120395Symphony Locating Bar, PH StyleQfixJAI2025-12-02
00841962120401Portrait Head Only Mask Adapter for Access SupineQfixJAI2025-12-02
00841962120418Portrait Head & Neck Mask Adapter for Access SupineQfixJAI2025-12-02
10841962119457Symphony Locating Bar, Prodigy2™QfixJAI2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAI2025-10-23
00841439114841ZiFix TraverseMEDTEC, INC.JAI2025-09-12
00841962120340Edge Guide SystemQfixJAI2025-09-11
00841962119481Symphony™QfixJAI2025-07-09
00841962119498AirDrive Trolley™QfixJAI2025-07-09
00841962119504Access Arm SupportQfixJAI2025-07-09
00841962119511Access Wrist SupportQfixJAI2025-07-09
00841962119528AirShuttle Locating BarQfixJAI2025-07-09
00841962119535AirShuttle Locating BarQfixJAI2025-07-09
00841962119542AirShuttle Transfer HandleQfixJAI2025-07-09
00841962119559InfinityLock™QfixJAI2025-07-09
00841962119573AirShuttle Transfer HandleQfixJAI2025-07-09
00841962119580InfinityLock™QfixJAI2025-07-09
00841962119597AltaQfixJAI2025-07-09
00841962119603AltaQfixJAI2025-07-09
00841962119610Locating BarQfixJAI2025-07-09
00841962119627FlexLock™QfixJAI2025-07-09
00841962119689Stradivarius™QfixJAI2025-07-09
00841962119696Encompass™QfixJAI2025-07-09
00841962119702Encompass™QfixJAI2025-07-09
00841962119719Encompass™QfixJAI2025-07-09
00841962119726AltaQfixJAI2025-07-09