Singapore HSA registration DE0017322
Siemens Acuson P500 Diagnostic Ultrasound System
Singapore·CLASS B·Siemens Medical Solutions USA, Inc.·Registered July 15, 2015Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0017322
- Registration Date
- July 15, 2015
- Change Notification Approval Date
- March 18, 2025
- Retention Due Date
- July 14, 2025
Product description
The ACUSON P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Pelvic, Neonatal, Cardiac, Intracardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial)} 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.
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)
- Protective Sleeves Non-Sterile Cover Sterile Cover Needle Guide Needle Guide CH5-2 VF10-5 P4-2 EC9-4 Acuson P500 Diagnostic Ultrasound System Biopsy Starter Kit Biopsy Bracket VF13-5 CW2 CW5 P8-4 VF16-5 ECG Lead Euro Type(IEC) CH5-2 P4-2 EC9-4 VF10-5 VF13-5 ECG Lead USA Type(AHA) Biopsy Starter Kit P500 VA10F SW P500 Software VB10A L10-5v P500 Software VB10B Software Version VB10C (2.0.10) SW Inst. USB P500 r2.0 (VB10D) SW Inst. USB P500 r2.0 (VB10E) Biopsy Starter Kit Biopsy Starter Kit Biopsy Starter Kit
- Model Identifier(s)
- 04510947 08990418 08990426 10041822 10041823 10136141 10136142 10136143 10136144 10785577 10787043 10787350 10789372 10789380 10789381 11014543 11014552 11014623 11015392 11015393 11015394 11015395 11015396 11284295 11291775 11291787 11319650 11319682 11361603 11370746 11574205 11575110 4838749 4838756 7472314
About this record
Access comprehensive regulatory information for Siemens Acuson P500 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 DE0017322 and owned by Siemens Medical Solutions USA, Inc.. The device was registered on July 15, 2015.
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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