Site~Rite Halcyon Diagnostic Ultrasound System

GUDID 06945121412056

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06945121412056
NIH Device Record Keye70d820b-750a-437a-8902-b0c26e98e985
Commercial Distribution StatusIn Commercial Distribution
Brand NameSite~Rite Halcyon Diagnostic Ultrasound System
Version Model NumberSite~Rite Halcyon
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
GS106945121412018 [Primary]
GS106945121412056 [Package]
Contains: 06945121412018
Package: [1 Units]
In Commercial Distribution
GS106945121412063 [Package]
Contains: 06945121412018
Package: [1 Units]
In Commercial Distribution
GS106945121412070 [Package]
Contains: 06945121412018
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 Date2017-08-04

Devices Manufactured by CHISON Medical Technologies Co., Ltd.

06945121415538 - Micro convex probe2024-12-04
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

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