i9 Diagnostic Ultrasound System

GUDID 06945121407304

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06945121407304
NIH Device Record Key993b6eb8-939d-49a4-b79d-8e60c47ef46f
Commercial Distribution StatusIn Commercial Distribution
Brand Namei9 Diagnostic Ultrasound System
Version Model Numberi9
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
GS106945121406574 [Primary]
GS106945121407090 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407106 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407113 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407120 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407137 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407144 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407151 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407168 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407175 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407182 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407199 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407205 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407212 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407229 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407236 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407243 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407250 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407267 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407274 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407281 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407298 [Package]
Contains: 06945121406574
Package: [1 Units]
In Commercial Distribution
GS106945121407304 [Package]
Contains: 06945121406574
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.