Singapore HSA registration DE0508590
Fujifilm Sonosite ST Ultrasound System
Singapore·CLASS B·Fujifilm SonoSite, Inc·Registered October 20, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0508590
- Registration Date
- October 20, 2023
- Change Notification Approval Date
- October 21, 2024
- Retention Due Date
- October 19, 2025
Product description
The Sonosite ST ultrasound system 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: Abdominal Needle guidance Adult cephalic Ophthalmic Cardiac adult Pediatric Cardiac pediatric Peripheral vessel Fetal - OB/GYN Small organ (breast, thyroid, testicles, prostate) Musculoskeletal (conventional) Transrectal Musculoskeletal (superficial) Transvaginal
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
Model information
- Model Name(s)
- NEEDLE GUIDE STARTER KIT, IC10- 3 SERIES Assembly PowerPark Dock Module Transducer, L12-3 Transducer, C10-3 Transducer, C5-1 Transducer, L15-4 Transducer, IC10-3 Transducer, L19-5 Transducer, P5-1 PowerPark Stand Module AC/DC Power Supply Sonosite Stand Battery NEEDLE GUIDE STARTER KIT, C5-1 SERIES, INFINITI PLUS NEEDLE GUIDE STARTER KIT, C10-3 SERIES, INFINITI PLUS NEEDLE GUIDE BRACKET, C10-3 SERIES, INFINITI PLUS NEEDLE GUIDE STARTER KIT, L12-3 SERIES, INFINITI PLUS NEEDLE GUIDE STARTER KIT, L15-4 SERIES, INFINITI PLUS NEEDLE GUIDE STARTER KIT, L19-5 SERIES, INFINITI PLUS NEEDLE GUIDE STARTER KIT, L19-5 SERIES, ACCUSITE Small Basket (Kit #2) Sonosite ST Ultrasound System SONOSITE ST STAND HEAD SONOSITE ST STAND Large Basket (Kit A) Large baskets (Kit B) Small Basket (Kit#1)
- Model Identifier(s)
- P03883-06 P12834-40 P22916-20 P23117-20 P23119-21 P23120-20 P23121-22 P23972-22 P24087-22 P25003-15 P25255-02 P27003-21 P27060-01 P27062-01 P27063-01 P27064-01 P27066-01 P27068-01 P27070-01 P28950-01 P31200-21 P31203-20 P31204-20 P31787-01 P31790-01 P31960-01
About this record
Access comprehensive regulatory information for Fujifilm Sonosite ST 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 DE0508590 and owned by Fujifilm SonoSite, Inc. The device was registered on October 20, 2023.
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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