kVue™ CT Overlay RT-4550KVGEL

GUDID 10841962108925

kVue CT Base for GE Lightspeed and HiSpeed CT for 231 cm long cradle

Qfix

Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system
Primary Device ID10841962108925
NIH Device Record Keyca6b8c50-f4ce-49a0-90ab-ace76025e3a3
Commercial Distribution StatusIn Commercial Distribution
Brand NamekVue™ CT Overlay
Version Model NumberRT-4550KVGEL
Catalog NumberRT-4550KVGEL
Company DUNS808875397
Company NameQfix
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com

Device Dimensions

Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter
Length231 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110841962108925 [Primary]

FDA Product Code

JAICouch, radiation therapy, powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-12-07
Device Publish Date2016-09-13

On-Brand Devices [kVue™ CT Overlay]

10841962110997KVue CT Overlay for Canon Aquilion CT for 244cm long cradle
10841962109014KVue CT Base for Toshiba Aquilion CT For 215cm long cradle
10841962109007kVue CT Overlay, Siemens Biograph PET/CT
10841962108994kVue CT Overlay, Siemens
10841962108987kVue CT Base for Siemens Somatom Definition for 240cm long cradle
10841962108970kVue CT for Siemens Somatom Balance, Emotion For 217cm long cradle
10841962108963kVue CT for Siemens Somatom Plus 4, Volume For 244cm long cradle
10841962108956KVue CT Base for Philips Brilliance CT For 250cm long cradle
10841962108949kVue CT Base for GE Lightspeed RT CT For 207 cm long cradle
10841962108932kVue CT GE Prospeed
10841962108925kVue CT Base for GE Lightspeed and HiSpeed CT for 231 cm long cradle
10841962108918kVue CT Base for GE Lightspeed VCT Scanner For 262 cm long cradle, requires at least 1 insert
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.