Q Series Diagnostic Ultrasound System

GUDID 06945121400060

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06945121400060
NIH Device Record Keyc64d5cc9-60ab-4e14-8d8e-0135bf776612
Commercial Distribution StatusIn Commercial Distribution
Brand NameQ Series Diagnostic Ultrasound System
Version Model NumberQ9
Company DUNS544914187
Company NameCHISON Medical Technologies Co., Ltd.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106945121400060 [Primary]
GS106945121402064 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402071 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402088 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402095 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402101 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402118 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402125 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402132 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402149 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402156 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402163 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402170 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402187 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402194 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402200 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402217 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402224 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402231 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402248 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402255 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402262 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402279 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402286 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402293 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402309 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402316 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402323 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121402330 [Package]
Package: [1 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Q Series Diagnostic Ultrasound System]

06945121400060Q9
06945121401241Q5

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