DTX Studio™ diagnose 300123_V1.4_WIN64

GUDID 07332747153101

DTX Studio diagnose 1.4 for Windows 64-bit

Nobel Biocare AB

Radiology DICOM image processing application software
Primary Device ID07332747153101
NIH Device Record Keya2c66373-b337-49d4-bfe0-cf52dcceb6f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDTX Studio™ diagnose
Version Model Number1.4
Catalog Number300123_V1.4_WIN64
Company DUNS353939929
Company NameNobel Biocare AB
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747153101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2018-06-07

On-Brand Devices [DTX Studio™ diagnose]

07332747153118DTX Studio diagnose 1.4 for Mac
07332747153101DTX Studio diagnose 1.4 for Windows 64-bit
07332747152173DTX Studio diagnose 1.3 for Mac
07332747152166DTX Studio diagnose 1.3 for Windows 64-bit

Trademark Results [DTX Studio]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DTX STUDIO
DTX STUDIO
79205188 5537635 Live/Registered
Nobel Biocare Services AG
2016-12-22

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