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ACUSON SEQUOIA and SEQUOIA SELECT DIAGNOSTIC ULTRASOUND SYSTEM - HSA Registration DE0510601

Access comprehensive regulatory information for ACUSON SEQUOIA and SEQUOIA 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 DE0510601 and owned by Siemens Medical Solutions USA, Inc.. The device was registered on April 16, 2025.

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
DE0510601
ACUSON SEQUOIA and SEQUOIA SELECT DIAGNOSTIC ULTRASOUND SYSTEM
HSA Registration Number: DE0510601
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Product Description

The ACUSON Sequoia and Sequoia 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: Fetal, Abdominal1, Pediatric, Neonatal Cephalic, Small Parts2, OB/GYN3, Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal, and Peripheral Vascular. The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal, adult cephalic, 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
General Hospital
Registration Information
Registration Number
DE0510601
Registration Date
April 16, 2025
Retention Due Date
April 15, 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 9EC4 Transducer CW2 Transducer CW5 Transducer 4V1 Transducer 8V3 Transducer 10V4 Transducer ACUSON Sequoia Diagnostic Ultrasound System Z6T Transducer 14L5 Transducer 15L4 Transducer 11M3 Transducer 7L2 Transducer 9VE4 Transducer 7VC2 Transducer 18H6 Transducer 5Z1 Transducer 5C1 Transducer 5V1 Transducer 10EV3 Transducer 9C2 Transducer 9C3 Transducer 18L6 Transducer HLX Transducer 11M2 Transducer ACUSON Sequoia Select Diagnostic Ultrasound System
Model Identifier(s)
10787114 10787116 10787117 10789380 10789381 11014576 11014578 11014579 11148775 11151267 11254090 11289427 11289561 11289562 11289564 11289565 11289567 11290766 11291794 11291796 11502928 11503103 11575182 11575184 11575216 11653755 11658635