Vitrea Software Toshiba Package

GUDID 04987670102493

This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name Vitrea Software Toshiba Package. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now Vitrea Software Package.

CANON MEDICAL SYSTEMS CORPORATION

Radiology DICOM image processing application software
Primary Device ID04987670102493
NIH Device Record Key5fe1b51f-cb4b-41df-8cd7-d8d3afc2e4ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitrea Software Toshiba Package
Version Model NumberVSTP-001A
Company DUNS690575113
Company NameCANON MEDICAL SYSTEMS CORPORATION
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx
Phone+1-8004211968
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS104987670102493 [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 Date2018-03-02

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

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04987670106095 - Aquilion Serve SP2024-07-12
04987670100925 - BIOPSY ADAPTOR2024-04-22
04987670104626 - LINEAR ARRAY TRANSDUCER2024-04-22
04987670104633 - LINEAR ARRAY TRANSDUCER2024-04-22
04987670104640 - ENDOCAVITARY TRANSDUCER2024-04-22
04987670104664 - CONVEX ARRAY TRANSDUCER2024-04-22

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