FDA.reportPublic FDA data

VacQfix™

Primary DI
10841962118993
Brand
VacQfix™
Company
Qfix
Model
RT-4517-12075F35
Catalog number
RT-4517-12075F35
Device description
VacQfix Cushion 120cm x 75cm, 35L Fill
Published
2022-02-03
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060671000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060671000KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUSWfr/Aquaplast Corp.2006-05-04JAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841962118993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084196211899310841962118993

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
Length120Centimeter
Total Volume35Liter
Width75Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(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
00841962120500Single Hand Extremity FibreplastRT-E778KPR2H2026-06-05
00841962120517Knee / Elbow Extremity FibreplastRT-E778KPR2NE2026-06-05
00841962120524Foot Extremity FibreplastRT-E778KPR3FT2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastRT-E778KPR3HS2026-06-05
00841439115305MultiFix 2RT-54112026-06-04
00841439115312MultiFix 2 - JointGlowRT-54122026-06-04
00841439115329Extremity RiserRT-54132026-06-04
00841439115336Extremity Riser - JointGlowRT-54142026-06-04
00841439115343MultiFix Indexing PostRT-54152026-06-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120425Opti Handle Thermoplastic AdapterQfixJAI2026-05-18
00841962120456Alta for HexaPODQfixJAI2026-01-14
00841439115152Upright Arm Positioner MEDTEC, INC.JAI2026-01-08
00841962120388Lumen AirShuttleQfixJAI2025-12-02
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