i7 Diagnostic Ultrasound System

GUDID 06945121406864

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06945121406864
NIH Device Record Keydb4327eb-89dc-4c98-98e2-53f37f4190e3
Commercial Distribution StatusIn Commercial Distribution
Brand Namei7 Diagnostic Ultrasound System
Version Model Numberi7
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
GS106945121406550 [Primary]
GS106945121406659 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406666 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406673 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406680 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406697 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406703 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406710 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406727 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406734 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406741 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406758 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406765 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406772 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406789 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406796 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406802 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406819 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406826 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406833 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406840 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406857 [Package]
Contains: 06945121406550
Package: [1 Units]
In Commercial Distribution
GS106945121406864 [Package]
Contains: 06945121406550
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.