Pure Global

GE Voluson S10 Ultrasound System - HSA Registration DE0018662

Access comprehensive regulatory information for GE Voluson S10 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 DE0018662 and owned by GE Ultrasound Korea Ltd. The device was registered on October 14, 2016.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0018662
GE Voluson S10 Ultrasound System
HSA Registration Number: DE0018662
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Intended for use by a qualified physician or sonographer for ultrasound evaluation in the following clinical application: Image Acquisition for diagnostic purposes including measurements on acquired image. The device is intended for ultrasound evaluation of Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0018662
Registration Date
October 14, 2016
Retention Due Date
October 13, 2025
Product Owner
Short Name
Ge Ultrasound Korea Ltd
Address
9, Sunhwan-ro 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, KOREA, REPUBLIC OF
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 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
4C-RS 8C-RS 12L-RS 9L-RS C1-5-RS ML6-15-RS Voluson S10 BT16 SW OPTION KIT for Coded contrast imaging SW OPTION KIT for Anatomical M-mode SW OPTION KIT for Elastography SW OPTION KIT for Advanced VCI SW OPTION KIT for SonoAVC SW OPTION KIT for SonoL&D SW OPTION KIT for SonoVCAD labor SW OPTION KIT for STIC SW OPTION KIT for SonoVCADheart SW OPTION KIT for TUI SW OPTION KIT for VOCAL II SW OPTION KIT for inversion SW OPTION KIT for 4D biopsy SW OPTION KIT for HDlive (for VS10) ECG Option Kit VS10 Drawer SW OPTION KIT - 3D/4D Activation SW OPTION KIT - Advanced 3D/4D Package SW OPTION KIT for single view CWD Option Kit (with SW Option) SW OPTION KIT for SW DVR DPS with Battery Pack DPS with Battery Pack for MC only Battery Pack (LPC only) 12S-RS 3Sc-RS PEC63; Biopsy for RIC5-9 (<1.6 mm) USB FootSwitch - 3 Buttons 40in PATIENT MONITOR EU US 32 inch Monitor RAB6-RS IC9-RS RIC5-9A-RS
Model Identifier(s)
H4000SR H40402LS H40402LY H40442LL H40462LA H40462LM H44792LW H44842LB H44842LC H44842LD H44842LE H44842LF H44842LG H44842LH H44842LJ H44842LK H44842LL H44842LM H44842LN H44842LP H44842LR H44852LJ H44852LL H44862LZ H44872LA H44872LE H44882LW H44892LE H44892LF H44892LG H44892LH H44901AB H45041DL H46721R H46732LF H48681TL H48681TP H48691LP H48691PJ H48701EJ