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Singapore HSA registration DE0015211

FUJIFILM Sonosite X-Porte Ultrasound System

Singapore flagSingapore·CLASS B·FUJIFILM Sonosite, Inc.·Registered April 21, 2014
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0015211
Registration Date
April 21, 2014
Change Notification Approval Date
May 31, 2019
Retention Due Date
April 20, 2026
Product description
The FUJIFILM SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal – OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Pediatric, Small Organ (breast, thyroid, testicles, prostate), Trans-vaginal, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Cardiac Adult, Cardiac Pediatric, Peripheral vessel
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 FUJIFILM HEALTHCARE ASIA PACIFIC PTE LTD
Address
24 SIN MING LANE, MIDVIEW CITY, #05-91, SINGAPORE 573970 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model information
Model Name(s)
Field upgrade, X-Porte ultrasound system 1.0 X-Porte Control Panel C60xp/5-2 MHz transducer ICTxp/9-5 MHz transducer P21xp/5-1 MHz transducer Tranducer - C11xp / 8-5 MHz L38xp/10-5MHz transducer L25xp/13-6 MHz transducer HFL50xp/15-6 MHz transducer X-Porte Clinical Monitor X-Porte TTC X-Porte Dock with DVR ECG Option Biopsy Guide Starter Kit for the C60xp curved array transducer Tranducer - HFL38xp / 13-6 MHz X-Porte ultrasound engine Acute Care Worksheets MSK Worksheets Transducer - P10xp / 8-4 MHz X-Porte System and Stand X-Porte System and Stand (no printer) Acute Care Visual Guide Anesthesiology Visual Guide Procedures Visual Guide Transducer - HSL25xp / 13-6 MHz X-Porte System and Stand Transducer - C35xp / 8-3 MHz Transducer - TEExp/8-3 MHz ECG Slave Cable and Adapter Kit Transducer rP19xp/ 5-1 MHz
Model Identifier(s)
L15610 P14027 P14561 P14562 P14563 P14564 P14565 P14566 P14567 P14627 P14644 P15164 P15169 P15679 P16038 P16055 P16851 P16852 P17780 P17860 P17870 P18001 P18002 P18003 P18657 P19220 P19617 P19620 P20262 P22557
About this record

Access comprehensive regulatory information for FUJIFILM Sonosite X-Porte 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 DE0015211 and owned by FUJIFILM Sonosite, Inc.. The device was registered on April 21, 2014.

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