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ACUSON MAPLE and MAPLE SELECT DIAGNOSTIC ULTRASOUND SYSTEM - HSA Registration DE0508685

Access comprehensive regulatory information for ACUSON MAPLE and MAPLE SELECT DIAGNOSTIC 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 DE0508685 and owned by Siemens Medical Solutions USA, Inc.. The device was registered on November 23, 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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CLASS B
DE0508685
ACUSON MAPLE and MAPLE SELECT DIAGNOSTIC ULTRASOUND SYSTEM
HSA Registration Number: DE0508685
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Product Description

The ACUSON Maple ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, and Musculoskeletal applications using different ultrasound transducers for different applications. The ACUSON Maple Select ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Vascular, Urology, Echocardiography, and Musculoskeletal applications using different ultrasound transducers for different applications.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0508685
Registration Date
November 23, 2023
Retention Due Date
November 22, 2025
Product Owner
Short Name
Siemens Medical Solutions USA, Inc.
Address
22010 S.E. 51st Street, Issaquah, WA 98029, UNITED STATES
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
P4-2 Transducer CW2 Doppler Pencil CW5 Doppler Pencil 7C2 Transducer 10MC3 Transducer 16L4 Transducer 8V4 Transducer 11M3 Transducer L10-5v Transducer 5VT Transducer 9VC2 Transducer 9VE4 Transducer C5-2v Transducer 14L4a Transducer Acuson Maple Diagnostic Ultrasound System Acuson Maple Select Diagnostic Ultrasound System 5C1a Transducer
Model Identifier(s)
10136143 10789380 10789381 11268277 11268679 11284846 11284847 11284923 11319682 11370949 11575443 11575444 11711157 11711446 11711750 11711779 11711957