Q Series Diagnostic Ultrasound System

GUDID 06945121401241

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system
Primary Device ID06945121401241
NIH Device Record Key795d1d99-9533-4f7d-9cc6-513ac49f3343
Commercial Distribution StatusIn Commercial Distribution
Brand NameQ Series Diagnostic Ultrasound System
Version Model NumberQ5
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
GS106945121400039 [Primary]
GS106945121401227 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401234 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401241 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401258 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401265 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401272 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401289 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401296 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401302 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401319 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401326 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401333 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401340 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401357 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401364 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401371 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401388 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401395 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401401 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401418 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401425 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401432 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401449 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401456 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401463 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401470 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401487 [Package]
Contains: 06945121400039
Package: [1 Units]
In Commercial Distribution
GS106945121401494 [Package]
Contains: 06945121400039
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 Date2016-09-20

On-Brand Devices [Q Series Diagnostic Ultrasound System]

06945121400060Q9
06945121401241Q5
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