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FUJIFILM SonoSite SII Ultrasound System - HSA Registration DE0018991

Access comprehensive regulatory information for FUJIFILM SonoSite SII 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 DE0018991 and owned by Fujifilm SonoSite, Inc. The device was registered on February 20, 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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CLASS B
DE0018991
FUJIFILM SonoSite SII Ultrasound System
HSA Registration Number: DE0018991
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Product Description

is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals 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, Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric and Peripheral Vessel, transrectal.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0018991
Registration Date
February 20, 2017
Change Notification Approval Date
June 09, 2020
Retention Due Date
February 19, 2026
Product Owner
Short Name
Fujifilm SonoSite, Inc
Address
21919 30th Dr. SE, Bothell, WA 98021-3904, 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 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model Information
Model Name(s)
C11x/8-5 MHz Transducer ICTx/8-5 MHz Transducer L25x/13-6 MHz Transducer HFL50x/15-6 MHz Transducer P10x/8-4 MHz Transducer Transducer, C8x/8-5 MHZ Power Supply SiteLink Image Manager L38xi/10-5 MHz Transducer PowerPark Stand Module PowerPark Dock PowerPack Bar Code Scanner Kit P11x/10-5 MHz Transducer Wireless Kit L38xi/10-5 MHz Transducer, Armored HFL38xi/13-6 MHz Transducer Transducer, HFL38xi/13 - 6 MHZ Armored SonoSite SII Ultrasound System Battery Pack HSL25x/13-6 MHz Transducer SonoSite SII Ultrasound System rP19x/5-1 MHz Transducer rC60xi/5-2 MHz Transducer SonoSite Patient Data Archival Software (PDAS) SonoSite SII Stand rP19x/5-1 MHz Transducer, Armored rC60xi/5-2 MHz Transducer, Armored Transducer, C35x/ 8-3 MHZ Transducer, L25x/13-6 MHZ, Armored Sonosite SII Ultrasound System Wireless Module
Model Identifier(s)
P07678 P07690 P07691 P07693 P07696 P08010 P09823 P10117 P12742 P12822 P12834 P13122 P14166 P16665 P17726 P19626 P20311 P20377 P20500 P20664 P20679 P20883 P21015 P21070 P21178 P21432 P21556 P21636 P21981 P22950 P24550 P24559