DIAGNOSTIC ULTRASOUND SYSTEM

GUDID 04987670104558

CANON MEDICAL SYSTEMS CORPORATION

General-purpose ultrasound imaging system
Primary Device ID04987670104558
NIH Device Record Key01ca7e93-ec31-42b0-ab25-fc3fe059c4aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIAGNOSTIC ULTRASOUND SYSTEM
Version Model NumberCUS-AGG00
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
GS104987670104558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-15
Device Publish Date2024-07-05

On-Brand Devices [DIAGNOSTIC ULTRASOUND SYSTEM]

04987670103469DIAGNOSTIC ULTRASOUND SYSTEM
04987670103452DIAGNOSTIC ULTRASOUND SYSTEM
04987670103353DIAGNOSTIC ULTRASOUND SYSTEM
04987670103346DIAGNOSTIC ULTRASOUND SYSTEM
04987670102981DIAGNOSTIC ULTRASOUND SYSTEM
04987670102523DIAGNOSTIC ULTRASOUND SYSTEM
04987670102516DIAGNOSTIC ULTRASOUND SYSTEM
04987670102509DIAGNOSTIC ULTRASOUND SYSTEM
04987670100765DIAGNOSTIC ULTRASOUND SYSTEM
04987670100758DIAGNOSTIC ULTRASOUND SYSTEM
04987670100741DIAGNOSTIC ULTRASOUND SYSTEM
04987670100734DIAGNOSTIC ULTRASOUND SYSTEM
04987670100727DIAGNOSTIC ULTRASOUND SYSTEM
04987670100710DIAGNOSTIC ULTRASOUND SYSTEM
04987670100703DIAGNOSTIC ULTRASOUND SYSTEM
04987670103780CUS-AA000
04987670104558CUS-AGG00
04987670104541CUS-AFL00
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