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GE Vivid iq Ultrasound System - HSA Registration DE0018959

Access comprehensive regulatory information for GE Vivid iq Ultrasound System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018959 and owned by GE Medical Systems (China) Co., Ltd.. The device was registered on February 14, 2017.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0018959
GE Vivid iq Ultrasound System
HSA Registration Number: DE0018959
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Product Description

The Vivid iq ultrasound unit is a general-purpose ultrasound system specialized for use in cardiac imaging by a qualified physician for ultrasound evaluation. It is designed for cardiovascular and shared services applications with indications including Fetal, OB, Abdominal, Pediatric, Small Organ, Neonatal and Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophagral, Tissue Biopsy, Intraoperative, IntraCardiac and Intraluminal.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0018959
Registration Date
February 14, 2017
Change Notification Approval Date
October 29, 2019
Retention Due Date
February 13, 2026
Product Owner
Short Name
GE Medical Systems (China) Co., Ltd.
Address
No. 19, Changjiang Road, WuXi National Hi-Tech Development, Zone Jiangsu, 214028, CHINA
Registrant
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model Information
Model Name(s)
4C-RS 8C-RS 12L-RS 9L-RS C1-5-RS L8-18i-RS ML6-15-RS FOOT SWITCH -MED GP26 12S-RS M5Sc-RS 6S-RS 3SC-RS 9T-RS P2D 6Tc-RS 6VT-D Vivid iq R2 Vivid iq R2 Premium Vivid iq R2 4D Vivid iq Upgrade R1 to R2 Vivid iq R2 PoC E8Cs-RS Vivid iq basic console Vivid iq generic cart Vivid iq multi probe port box Charge box w. 3 batteries Vivid iq Vivid iq Premium Vivid iq 4D 6VT Biplane or Triplane Upgrade kits Upgrade kits 4DAutoAVQ 4DAutoLVQ DicomConnectivityPackage DICOMMediaViewer MPEGVue and eVue AdvQScan Qanalysis LVOContrast AFI Smart stress Auto2DEF Rodent ICEProbeInterfaceModule CartoSound interface Vivid Compact Battery ICECord-RS W. Ferrite filter Vivid iq PoC
Model Identifier(s)
H4000SR H40402LS H40402LY H40442LL H40462LA H40462LF H40462LM H41642LS H44901AB H44901AG H45021RP H45041DL H45531YM H45551CA H45551ZE H45581BJ H48012BA H48012BB H48012BC H48012BD H48012BE H48062AF H48722AL H48722AM H48722AN H48722AR H48912AA H48912AB H48912AC H48912AD H48912AH H48912AJ H48912AL H48912AM H48912AN H48912AP H48912AR H48912AS H48912AT H48912AY H48912AZ H48922AB H48922AC H48922AD H48942AP H48942AR H48942AT H48952AR H48982AK