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Siemens Biograph Vision Quadra - HSA Registration DE0508015

Access comprehensive regulatory information for Siemens Biograph Vision Quadra in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508015 and owned by Siemens Medical Solutions USA, Inc.. The device was registered on April 18, 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
DE0508015
Siemens Biograph Vision Quadra
HSA Registration Number: DE0508015
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Product Description

A radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. The PET and CT portions of the system may be used independently or in combination. The PET and CT images may be transferred to other systems for radiation therapy planning or additional processing. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing,staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0508015
Registration Date
April 18, 2023
Change Notification Approval Date
April 24, 2025
Retention Due Date
April 17, 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)
Eagle Radiation Therapy Pallet UPMM - Signal White Biograph Vision Quadra Biograph Vision Quadra Software Syngo MI.PET/CT
Model Identifier(s)
10531406 10753310 10754273 10755525