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Fujifilm Sonosite ZX ultrasound system - HSA Registration DE0509890

Access comprehensive regulatory information for Fujifilm Sonosite ZX 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 DE0509890 and owned by Fujifilm SonoSite, Inc. The device was registered on October 09, 2024.

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 C
DE0509890
Fujifilm Sonosite ZX ultrasound system
HSA Registration Number: DE0509890
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Product Description

The Sonosite ZX 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, Ophthalmic, Adult cephalic, Pediatric, Cardiac adult, Peripheral vessel, Cardiac pediatric, Small organ (breast, thyroid, testicles, prostate), Fetal - OB/GYN, Transesophageal (cardiac), Musculoskeletal (conventional), Transrectal, Musculoskeletal (superficial), Transvaginal, Needle guidance. The Sonosite ZX system is intended to be used in medical practices, clinical environments, including healthcare facilities, hospitals, clinics, and clinical point-of-care for diagnosis of patients.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0509890
Registration Date
October 09, 2024
Retention Due Date
October 08, 2025
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 Kit, USB Bar Code Scanner, Jadak Transducer, L12-3 Transducer, C5-1 Transducer, L15-4 Transducer, IC10-3 Transducer, L19-5 Transducer, P5-1 AC Power Supply, Sonosite PX Sonosite PX Stand Battery NEEDLE GUIDE STARTER KIT, C5-1 SERIES, INFINITI PLUS NEEDLE GUIDE STARTER KIT, L12-3 SERIES, INFINITI PLUS NEEDLE GUIDE STARTER KIT, L15-4 SERIES, INFINITI PLUS ย NEEDLE GUIDE STARTER KIT, L19-5 SERIES, INFINITI PLUS NEEDLE GUIDE STARTER KIT, L19-5 SERIES, ACCUSITE Cable, Leadwires, ECG Sonosite ECG Module External ECG Connector Cable and Adapter Transducer, T8-3 Sonosite ECG Module Leadwires T8-3 ULT-2020 Ultrasound Leakage Tester Kit USB User Guide, Sonosite ZX Sonosite ZX Ultrasound System Sonosite ZX Stand Head Sonosite ZX Stand Triple Transducer Connect Kit, Storage/Power Supply Hardware, Sonosite ZX Kit Stand battery, Sonosite ZX KIT, B&W Printer, Sonosite ZX
Model Identifier(s)
P03883 P14166 P22916 P23119 P23120 P23121 P23972 P24087 P25969 P27003 P27060 P27064 P27066 P27068 P27070 P28427 P29077 P29189 P29465 P30130 P30248 P31316 P32000 P32001 P32002 P32003 P32004 P32006 P32007