ULTRASOUND WORKSTATION PACKAGE

GUDID 04987670101014

ULTRASOUND WORKSTATION PACKAGE

CANON MEDICAL SYSTEMS CORPORATION

Ultrasound imaging system workstation
Primary Device ID04987670101014
NIH Device Record Key3a89d639-d2b8-42fa-8412-eb480ce8af7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameULTRASOUND WORKSTATION PACKAGE
Version Model NumberUSWS-900A
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
GS104987670101014 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

On-Brand Devices [ULTRASOUND WORKSTATION PACKAGE]

04987670101014ULTRASOUND WORKSTATION PACKAGE
04987670100796ULTRASOUND WORKSTATION PACKAGE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.