SonoBook Series Diagnostic Ultrasound Systems

GUDID 06945121411172

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 ID06945121411172
NIH Device Record Keyfcaa5706-41db-49e6-8b66-7dc02a1b43fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoBook Series Diagnostic Ultrasound Systems
Version Model NumberSonoBook 9
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
GS106945121411172 [Primary]
GS106945121411721 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411738 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411745 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411752 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411769 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411776 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411783 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411790 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411806 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411813 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411820 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411837 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411844 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411851 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411868 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411875 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411882 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411899 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411905 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411912 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411929 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411936 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411943 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411950 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411967 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411974 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121411981 [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 Date2018-02-02

On-Brand Devices [SonoBook Series Diagnostic Ultrasound Systems]

06945121412681SonoBook 8
06945121411172SonoBook 9
06945121413305SonoBook 7
06945121414166SonoBook 5
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.