TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Elan

GUDID 04987670101632

This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Elan. Effective

CANON MEDICAL SYSTEMS CORPORATION

Full-body MRI system, superconducting magnet
Primary Device ID04987670101632
NIH Device Record Key65c948eb-8c66-4db1-9fc4-4d64e3e93abd
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Elan
Version Model NumberMRT-2020
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104987670101632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, nuclear magnetic resonance imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-02

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

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
04987670106033 - CONVEX ARRAY TRANSDUCER2024-04-22
04987670106057 - CONVEX ARRAY TRANSDUCER2024-04-22
04987670100680 - BIOPSY ADAPTOR2024-04-16

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