CHISON iVis Series & Q Series,i3 Diagnostic Ultras

GUDID 06945121409445

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06945121409445
NIH Device Record Key8b4eb97f-0d2b-4df0-aa16-0584ecd48d20
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHISON iVis Series & Q Series,i3 Diagnostic Ultras
Version Model Numberi3
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
GS106945121409315 [Primary]
GS106945121409346 [Package]
Contains: 06945121409315
Package: [1 Units]
In Commercial Distribution
GS106945121409353 [Package]
Contains: 06945121409315
Package: [1 Units]
In Commercial Distribution
GS106945121409360 [Package]
Contains: 06945121409315
Package: [1 Units]
In Commercial Distribution
GS106945121409377 [Package]
Contains: 06945121409315
Package: [1 Units]
In Commercial Distribution
GS106945121409384 [Package]
Contains: 06945121409315
Package: [1 Units]
In Commercial Distribution
GS106945121409391 [Package]
Contains: 06945121409315
Package: [1 Units]
In Commercial Distribution
GS106945121409407 [Package]
Contains: 06945121409315
Package: [1 Units]
In Commercial Distribution
GS106945121409414 [Package]
Contains: 06945121409315
Package: [1 Units]
In Commercial Distribution
GS106945121409421 [Package]
Contains: 06945121409315
Package: [1 Units]
In Commercial Distribution
GS106945121409438 [Package]
Contains: 06945121409315
Package: [1 Units]
In Commercial Distribution
GS106945121409445 [Package]
Contains: 06945121409315
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 Date2016-11-10

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.