Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family
Siemens Medical Solutions USA, Inc.The Symbia Pro.specta VA30A Family by Siemens is a hybrid SPECT/CT imaging system designed for healthcare professionals to help detect, localize, diagnose, and monitor various diseases including cardiovascular, neurological disorders, and cancer. It combines physiological imaging from SPECT with anatomical imaging from CT, enabling accurate assessment and radiotherapy planning. The device also supports low dose lung cancer screening and advanced image analysis software to assess and quantify pathologies.
Intended Use
The Symbia Pro.specta systems are intended for use by trained healthcare professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for evaluation of diseases such as cardiovascular disease, neurological disorders, and cancer. The images can also assist in radiotherapy treatment planning.
Technology
Hybrid imaging system consisting of integrated SPECT and spiral CT components. SPECT detects distribution of radiopharmaceuticals using planar, whole body, and tomographic imaging. CT produces cross-sectional images via x-ray transmission data reconstruction. Systems can operate independently or combined to produce fused images for anatomical localization and attenuation correction. Additional features include advanced cardiac quantification, high speed mode, remote reconstructions, and software for image acquisition, display and analysis.
Performance
Performance testing met applicable FDA and international standards including 21 CFR regulations, IEC 60601 series, NEMA NU-1, and ISO 14971 risk management. Software verification and system integration validation were completed. Bench testing for CT subsystem showed no changes from predicate device. Detector and collimator specifications remain unchanged. Cybersecurity controls implemented to prevent unauthorized access and use. The system is as safe and effective as predicate devices with no new safety or efficacy concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2024
1 month - 2
FDA Approval
10/30/2024
Other devices from Siemens Medical Solutions USA, Inc.
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