Vitrea Software Package

GUDID 04987670105005

CANON MEDICAL SYSTEMS CORPORATION

Radiology PACS software
Primary Device ID04987670105005
NIH Device Record Key4c11c559-5b72-4183-914e-0a3f95a039fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitrea Software Package
Version Model NumberVSTP-002A
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104987670105005 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-02
Device Publish Date2023-04-24

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

04987670104541 - DIAGNOSTIC ULTRASOUND SYSTEM2024-07-15
04987670104558 - DIAGNOSTIC ULTRASOUND SYSTEM2024-07-15
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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