Diagnostic Ultrasound System

GUDID 06970672750012

Guangzhou Sonostar Technologies Co., Ltd.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

Primary Device ID	06970672750012
NIH Device Record Key	f9598fb4-51a7-4d28-997a-cb5d6451a3b9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Diagnostic Ultrasound System
Version Model Number	C5
Company DUNS	543263098
Company Name	Guangzhou Sonostar Technologies Co., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970672750012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171926

FDA Product Code

ITX	Transducer, Ultrasonic, Diagnostic