kVue™ CT Overlay RT-4550KVTAQ2

GUDID 10841962110997

KVue CT Overlay for Canon Aquilion CT for 244cm 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 Indexed-immobilization patient positioning system
Primary Device ID10841962110997
NIH Device Record Keyd4e1b9c6-8bea-4f8e-9581-f37e07f73393
Commercial Distribution StatusIn Commercial Distribution
Brand NamekVue™ CT Overlay
Version Model NumberRT-4550KVTAQ2
Catalog NumberRT-4550KVTAQ2
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
Phone+1(610)268-0585
EmailCompliance@qfix.com

Device Dimensions

Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter
Length244 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110841962110997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAICouch, radiation therapy, powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-22
Device Publish Date2019-10-14

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.