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GE Vscan Extend ultrasound system - HSA Registration DE0019480

Access comprehensive regulatory information for GE Vscan Extend 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 DE0019480 and owned by GE Vingmed Ultrasound AS. The device was registered on August 04, 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
DE0019480
GE Vscan Extend ultrasound system
HSA Registration Number: DE0019480
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Product Description

A general purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, and triage. With phased array transducer on the sector probe, the specific clinical applications and exam types include: Cardiac;Abdominal;Renal;OB/GYN;Urology;Fetal,Evaluation of Presence of Fluid;Imaging Guidance for Needle/Catheter Placement;Peripheral Vascular Imaging;Thoracic/Lung;Adult Cephalic;Pediatrics. With addition of linear array transducer on single dual headed probe solution, the specific clinical applications and exam types are expanded to include: Peripheral vascular imaging;Procedure Guidance for Arterial or Venous;Small Organs;Musculoskeletal;Evaluation of Presence of Fluid;Thoracic/Lung;Ophthalmic;Pediatrics.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0019480
Registration Date
August 04, 2017
Change Notification Approval Date
October 04, 2022
Retention Due Date
August 03, 2025
Product Owner
Short Name
GE Vingmed Ultrasound AS
Address
Strandpromenaden 45, N-3191 Horten, NORWAY
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)
External battery charger Vscan Extend Dual USB Vscan Extend Dual Wi-Fi Vscan Extend Dual DICOM Vscan Extend Sector USB Vscan Extend Sector Wi-Fi Vscan Extend Sector DICOM
Model Identifier(s)
H41212SA H41212YY H41212YZ H41212ZA H41212ZB H41212ZC H41212ZD