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Siemens Symbia Pro.specta - HSA Registration DE0507758

Access comprehensive regulatory information for Siemens Symbia Pro.specta in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507758 and owned by Siemens Medical Solutions USA, Inc.. The device was registered on February 08, 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 C
DE0507758
Siemens Symbia Pro.specta
HSA Registration Number: DE0507758
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Product Description

The Symbia Pro.specta is a radiological imaging system that combines a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. The SPECT system is intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data, and the CT system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0507758
Registration Date
February 08, 2023
Change Notification Approval Date
May 24, 2024
Retention Due Date
February 07, 2026
Product Owner
Short Name
Siemens Medical Solutions USA, Inc.
Address
2501 North Barrington Road, Hoffman Estates, IL 60192, 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)
Corridors4DM Cedar-Sinai Cardiac Suite Collimator Asm Symbia LPHR-N Symbia Pro.specta Q3 Symbia Pro.specta X3 Symbia Pro.specta X7 MI View&GO Symbia Pro.specta Software SPECT-CT (VA10A) Symbia Pro.specta Software SPECT-CT (VA10B) IVY EXT ECG 7600 w/Chart Recorder AHA IVY EXT ECG 7600 w/Chart Recorder IEC Collimator Asm Smart Zoom SMARTZOOM UHR XL COLLIMATOR ASM Internal ECG Internal ECG ICSi - 1h IRSi โ€“ 1b IRSi - 1c ICSi - 1m IRSi -1a HI - EN Collimator Asm Symbia Medium Energy Collimator Asm Symbia LEAP Collimator Asm Symbia HI_RES Collimator Asm Symbia Pin Hole Collimator Asm Symbia UHRES Collimator Asm Symbia
Model Identifier(s)
10764037 10764038 10764062 11364751 11364752 11364753 11431534 11518631 11518676 14415734 14422381 14423562 14423563 14423581 14423582 14423587 14423607 14423608 14423700 14423701 7835445 7835452 7835460 7835494 7835510 7835528