SonoMax Series Digital Color Doppler Ultrasound System

GUDID 06945121415200

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06945121415200
NIH Device Record Key4c4657c0-36bd-4c9d-af70-53b69c769e46
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoMax Series Digital Color Doppler Ultrasound System
Version Model NumberSonoMax 7
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
GS106945121415200 [Primary]
GS106945121415217 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415224 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415231 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415248 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415293 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415309 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415316 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415323 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415330 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415347 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415354 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415361 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415378 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415453 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415460 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415477 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415484 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415491 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415507 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415514 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415521 [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 Date2024-08-23
Device Publish Date2024-08-15

On-Brand Devices [SonoMax Series Digital Color Doppler Ultrasound System]

06945121415200SonoMax 7
06945121414814SonoMax 9
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