4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE

GUDID 04987670102370

4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE

CANON MEDICAL SYSTEMS CORPORATION

Ultrasound imaging system workstation
Primary Device ID04987670102370
NIH Device Record Key18d6d39c-357d-4f14-82e6-295e936aa80e
Commercial Distribution Discontinuation2019-11-06
Commercial Distribution StatusNot in Commercial Distribution
Brand Name4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE
Version Model NumberUSWP-100A
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
GS104987670102370 [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 Number5
Public Version Date2019-11-06
Device Publish Date2016-09-01

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

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04987670004513 - MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER2022-09-27
04987670104176 - LINEAR ARRAY TRANSDUCER2022-09-27
04987670104831 - Vantage Fortian2022-04-25
04987670103780 - DIAGNOSTIC ULTRASOUND SYSTEM2021-12-24
04987670103810 - PET-CT SCANNER2021-12-22 This device is used to acquire transaxial images of any desired region of the body, providing a wide range of diagnostic capabil

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