Pure Global

Siemens Biograph Vision Systems - HSA Registration DE0503531

Access comprehensive regulatory information for Siemens Biograph Vision Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503531 and owned by Siemens Medical Solutions USA, Inc.. The device was registered on August 30, 2019.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0503531
Siemens Biograph Vision Systems
HSA Registration Number: DE0503531
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of physiologic and anatomic information. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. 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
DE0503531
Registration Date
August 30, 2019
Change Notification Approval Date
October 04, 2023
Retention Due Date
August 29, 2025
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)
Uniform Source Shield - Medium Eagle Radiation Therapy Pallet Universal Physiological Measurement Module (UPMM) Biograph Vision 450 Biograph Vision 600 (8 Ring/ 64 CT) Biograph Vision 450 Edge Biograph Vision 600 Edge (8 Ring/ Edge) Biograph Vision Software syngo MI.PET/CT (PETsyngo VG75B) MARS 2A Workstation HP Z8 G4 Service Pack VG76B Biograph Vision Software syngo MI.PET/CT (PETsyngo VG76B) Biograph mCT & Biograph Vision Software syngo MI.PET/CT (PETsyngo VG80A) Respiratory Gating System AZ-733VI Biograph Vision Software syngo MI.PET/CT (PETsyngo VG76A) Biograph mCT & Biograph Vision Software syngo MI.PET/CT (PETsyngo VG80B) Low Contrast CT Phantom CT Water Phantom for Vision Edge Systems CT Water Phantom for Vision 64 Systems Edge CT for Biograph Vision Biograph Ge-68 Sources - Biograph Vision Uniform Phantom Shield - fixed Hi-Performance MARS (standard with Vision 600, optional with Vision 450) Hi-Performance MARS Field Upgrade (upgrade for Vision 450) CT Split Filter Box
Model Identifier(s)
10097286 10531406 10533893 10749669 10749670 10749671 10749672 10751195 10751337 10753903 10754113 10754199 11154967 11217606 11430177 14415553 14421378 14421379 14422693 14422694 14422695 14423094 14423095 14423365