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Siemens Acuson SC2000 Diagnostic Ultrasound system - HSA Registration DE0010705

Access comprehensive regulatory information for Siemens Acuson SC2000 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 DE0010705 and owned by Siemens Medical Solutions USA, Inc.. The device was registered on September 12, 2012.

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
DE0010705
Siemens Acuson SC2000 Diagnostic Ultrasound system
HSA Registration Number: DE0010705
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Product Description

The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures 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. The typical examinations performed using the SC2000 Ultrasound System are: • Cardiac Imaging Applications and Analysis • Vascular Imaging Applications and Analysis • Superficial Imaging Applications • Intraoperative Imaging Applications • Transcranial Imaging Applications.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0010705
Registration Date
September 12, 2012
Change Notification Approval Date
November 17, 2021
Retention Due Date
September 11, 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
38 JALAN PEMIMPIN, M38, #07-06, SINGAPORE 577178 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
4Z1c 9L4 8V3 6C1HD ACUSON SC2000 Acuson SC2000 Workplace Z6Ms SC2000 Workplace CW2 8V3 4Z1c 9L4 V7M V5Ms Cable, CPM ECG Patient Harness, US Version Cable, CPM ECG Patient Harness, EU Version SC2000 Update SW, VB20B SC2000 Sys SW, VB20C SC2000 SYS SW, VB21A SC2000 SYS SW, VB21B USB SC2000 SYS SW, VB21B SC2000 WP HP_Z4XX S/W, VB21B SC2000 Update SW, VB21C SC2000 SYS SW, VB21D SC2000 SYS SW, VC10B SC2000 SYS SW, VC10B CW2 4V1c V5Ms 10V4 V7M
Model Identifier(s)
10033682 10035946 10041586 10135941 10433816 10433921 10436113 10441064 10789380 10789382 10789391 10789393 10855905 11013704 11147098 11148104 11288486 11288725 11290478 11291150 11291151 11506954 11507677 11508754 11510593 11510600 7472744 7695724 8263703 8266709 8664703