SonoBook Series Diagnostic Ultrasound Systems

GUDID 06945121412681

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 ID06945121412681
NIH Device Record Keyfaae6f48-87bd-46f2-8bbc-56454844a825
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoBook Series Diagnostic Ultrasound Systems
Version Model NumberSonoBook 8
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
GS106945121412681 [Primary]
GS106945121412698 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121412704 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121412711 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121412728 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121412735 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121412742 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121412759 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121412766 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121412773 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121412780 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121412797 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121412803 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121412810 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121412827 [Package]
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-06
Device Publish Date2018-11-05

On-Brand Devices [SonoBook Series Diagnostic Ultrasound Systems]

06945121412681SonoBook 8
06945121411172SonoBook 9
06945121413305SonoBook 7
06945121414166SonoBook 5
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