Singapore HSA registration DE0019480
GE Vscan Extend ultrasound system
Singapore·CLASS B·GE Vingmed Ultrasound AS·Registered August 04, 2017Device 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 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.
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
About this record
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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