Singapore HSA registration DE0505463
Sonosite PX Ultrasound System
Singapore·CLASS C·Fujifilm SonoSite, Inc·Registered February 10, 2021Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0505463
- Registration Date
- February 10, 2021
- Change Notification Approval Date
- March 03, 2025
- Retention Due Date
- February 09, 2026
Product description
The Sonosite PX 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 • Adult Cephalic • Neonatal Cephalic • Cardiac Adult • Cardiac Pediatric • Fetal - OB/GYN • Musculo-skeletal (Conventional) • Musculo-skeletal (Superficial) • Ophthalmic • Pediatric • Peripheral vessel • Small Organ (breast, thyroid, testicles, prostate) • Transesophageal (cardiac) • Transrectal • Transvaginal • Needle Guidance
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, L12-3/10.5-4.5 MHZ, ROHS Transducer, C10-3 TRANSDUCER, C5-1/5-1 MHZ, ROHS TRANSDUCER, L15-4/13-5 MHZ, ROHS TRANSDUCER, IC10-3/10-3 MHZ, ROHS TRANSDUCER, L19-5, ROHS TRANSDUCER, P5-1, ROHS Sonosite PX Ultrasound System SONOSITE PX STAND HEAD, 1.0 SONOSITE PX STAND POWERPARK STAND MODULE SONOSITE PX 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 Cable, Leadwires, ECG Sonosite ECG Module / ECG Module Sonosite ECG Module / ECG Module External ECG Connector Cable and Adapter Transducer, T8-3 Transducer, P11-3 Sonosite PX Field Case Sonosite ECG Module Leadwires T8-3 ULT-2020 Ultrasound Leakage Tester Kit Transducer, L13-6
- Model Identifier(s)
- P03883 P12834 P22916 P23117 P23119 P23120 P23121 P23972 P24087 P25000 P25001 P25002 P25003 P27003 P27060 P27062 P27063 P27064 P27066 P27068 P27070 P28427 P29069 P29076 P29189 P29465 P29671 P30031 P30130 P30248 P30257
About this record
Access comprehensive regulatory information for Sonosite PX Ultrasound System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505463 and owned by Fujifilm SonoSite, Inc. The device was registered on February 10, 2021.
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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