INTRA-CORPOREAL PROBE

GUDID 04987670001413

INTRA-CORPOREAL PROBE

CANON MEDICAL SYSTEMS CORPORATION

Rectal ultrasound imaging system transducer
Primary Device ID04987670001413
NIH Device Record Keye8b4048f-4eb5-4307-9f26-1c53aeaf0241
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTRA-CORPOREAL PROBE
Version Model NumberPVF-620ST
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
GS104987670001413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04987670001413]

Hydrogen Peroxide;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

04987670104862 - PHASED ARRAY TRANSDUCER2024-01-26
04987670104671 - CT SCANNER2023-12-11
04987670105005 - Vitrea Software Package2023-05-02
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

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