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Fujifilm SonoSite S- ICU™ Ultrasound System - HSA Registration DE0014512

Access comprehensive regulatory information for Fujifilm SonoSite S- ICU™ 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 DE0014512 and owned by FUJIFILM Sonosite, Inc.. The device was registered on December 20, 2013.

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
DE0014512
Fujifilm SonoSite S- ICU™ Ultrasound System
HSA Registration Number: DE0014512
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Product Description

The SonoSite S-Series Ultrasound Systems are 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, Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicles. prostate), Neonatal Cephalic, Adult Cephalic, Musculo-.skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult Cardiac Pediatric, Peripheral vessel

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0014512
Registration Date
December 20, 2013
Retention Due Date
December 19, 2025
Product Owner
Short Name
FUJIFILM Sonosite
Address
21919 30th Drive SE, Bothell, Washington, 98021, UNITED STATES
Registrant
Address
24 SIN MING LANE, MIDVIEW CITY, #05-91, SINGAPORE 573970
Importer
Address
24 SIN MING LANE, MIDVIEW CITY, #05-91, SINGAPORE 573970
Model Information
Model Name(s)
Needle Guide Starter Kit, L38, HFL38 Series Needle Guide Starter Kit, C60 Series TEEx / 8-3 MHz Transducer Needle Guide Starter Kit, P10 Series S-ICU Ultrasound System C11x / 8-5 MHz Transducer C60x / 5-2 MHz Transducer HFL38x / 13-6 MHz Transducer L25x / 13-6 MHz Transducer P10x / 8-4 MHz Transducer P21x / 5-1 MHz Transducer Battery – S Series Needle Guide Starter Kit, P21 Series Credentialing Worksheets L38xi / 10-5 MHz Transducer DICOM Bundle (Print, Store, Worklist, MPPS, Storage Commit) DICOM Upgrade Needle Guide Starter Kit, L38xi Series, Multi-angle Needle Guide Starter Kit, 18 G, L25 Series Needle Guide Starter Kit, 21 G, L25 Series Needle Guide Starter Kit, 22 G, L25 Series M-Mode MSK Worksheet ACO Technology Premier Transducer Package SonoMBe Continuous Wave Doppler Pulsed Wave Doppler PW/CW Doppler Bundle
Model Identifier(s)
P01300 P01882 P05183 P05187 P07577 P07678 P07680 P07682 P07691 P07696 P07698 P07753 P07873 P12007 P12742 P12820 P12824 P12868 P12920 P12922 P12924 P13614 P13622 P13624 P13626 P13984 P15223 P15225 P15227