SonoTouch Series Diagnostic Ultrasound System

GUDID 06945121408684

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06945121408684
NIH Device Record Key9b37f9ba-42f2-489d-8e60-6aa9c4d86ea3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoTouch Series Diagnostic Ultrasound System
Version Model NumberSonoTouch 30
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
GS106945121408264 [Primary]
GS106945121408608 [Package]
Contains: 06945121408264
Package: [1 Units]
In Commercial Distribution
GS106945121408615 [Package]
Contains: 06945121408264
Package: [1 Units]
In Commercial Distribution
GS106945121408622 [Package]
Contains: 06945121408264
Package: [1 Units]
In Commercial Distribution
GS106945121408639 [Package]
Contains: 06945121408264
Package: [1 Units]
In Commercial Distribution
GS106945121408646 [Package]
Contains: 06945121408264
Package: [1 Units]
In Commercial Distribution
GS106945121408653 [Package]
Contains: 06945121408264
Package: [1 Units]
In Commercial Distribution
GS106945121408660 [Package]
Contains: 06945121408264
Package: [1 Units]
In Commercial Distribution
GS106945121408677 [Package]
Contains: 06945121408264
Package: [1 Units]
In Commercial Distribution
GS106945121408684 [Package]
Contains: 06945121408264
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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-10-08

Devices Manufactured by CHISON Medical Technologies Co., Ltd.

06945121415385 - Linear probe2024-09-23
06945121414883 - Micro convex probe2024-08-26
06945121414814 - SonoMax Series Digital Color Doppler Ultrasound System2024-08-23
06945121415200 - SonoMax Series Digital Color Doppler Ultrasound System2024-08-23
06945121415194 - Digital Color Doppler Palm Ultrasound System2024-06-11
06945121414524 - SonoAir Series Digital Color Doppler Ultrasound System2023-08-15
06945121414531 - Convex probe2023-08-15
06945121414548 - Linear probe2023-08-15

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