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Singapore HSA registration DE0018709

Fujifilm Sonosite iViz Ultrasound System

Singapore flagSingapore·CLASS B·FUJIFILM Sonosite, Inc.·Registered November 07, 2016
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0018709
Registration Date
November 07, 2016
Change Notification Approval Date
April 15, 2019
Retention Due Date
November 06, 2025
Product description
The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging and fluid flow analysis, and for use in vital signs monitoring of the human body. Indications of Use: Fetal – OB/GYN, Abdominal, Pediatric, Small Organ (breast, thyroid, testicles, prostate), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Cardiac Adult, Cardiac Pediatric, Peripheral Vessel, Ophthalmic
Product Owner
Name
FUJIFILM Sonosite, Inc.
Short Name
FUJIFILM Sonosite
Address
21919 30th Drive SE, Bothell, Washington, 98021, UNITED STATES
Registrant
Name
Bluestone Corporation Pte Ltd
Address
24 SIN MING LANE, MIDVIEW CITY, #05-91, SINGAPORE 573970
Importer
Name
Bluestone Corporation Pte Ltd
Address
24 SIN MING LANE, MIDVIEW CITY, #05-91, SINGAPORE 573970
Model information
Model Name(s)
Battery Pack iViz Battery Charger Transducer P21V/5-1 MHz Transducer L38V/10-5 MHz iViz Battery Charger, Gang Plate iViz Battery Charger Power Supply iViz Ultrasound System Transducer C60v/5-2 MHz Transducer L25v/13-6 MHz
Model Identifier(s)
P18438 P18713 P18800 P19360 P19610 P19711 P20830 P21244 P21877
About this record

Access comprehensive regulatory information for Fujifilm Sonosite iViz 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 DE0018709 and owned by FUJIFILM Sonosite, Inc.. The device was registered on November 07, 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 DatabasePowered by Pure Global AIHSA Official DataCLASS B