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ACUSON ORIGIN DIAGNOSTIC ULTRASOUND SYSTEM - HSA Registration DE0508859

Access comprehensive regulatory information for ACUSON ORIGIN 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 DE0508859 and owned by Siemens Medical Solutions USA, Inc.. The device was registered on January 18, 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 B
DE0508859
ACUSON ORIGIN DIAGNOSTIC ULTRASOUND SYSTEM
HSA Registration Number: DE0508859
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Product Description

The ACUSON Origin 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, Pediatric, OB/GYNยน, Cardiac, Transesophageal, Intracardiacยฒ, Vascular, Adult Cephalic, and Peripheral Vascular. The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0508859
Registration Date
January 18, 2024
Change Notification Approval Date
May 02, 2025
Retention Due Date
January 17, 2026
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)
10L4 Transducer DAX Transducer CW2 Transducer CW5 Transducer 4V1 Transducer 8V3 Transducer 10V4 Transducer Z6T Transducer 14L5 Transducer 7L2 Transducer 5Z1 Transducer 5C1 Transducer 5V1 Transducer 9C2 Transducer HLX Transducer ACUSON Origin Diagnostic Ultrasound System
Model Identifier(s)
10787114 10787116 10789380 10789381 11014576 11014578 11014579 11151267 11254090 11289562 11290766 11291794 11291796 11503103 11575216 11668590