CT Scanner TSX-501R/1 V11.1
Canon Medical Systems CorporationThe CT Scanner TSX-501R/1 V11.1 by Canon Medical Systems Corporation is an advanced computed tomography system that uses a photon counting detector to capture high-quality cross-sectional volume images of the whole body. This system helps clinicians perform specialized studies by providing detailed imaging data to support diagnosis and treatment planning for adult patients.
Intended Use
Indicated to acquire and display cross-sectional volumes of the whole body (abdomen, pelvis, chest, extremities, and head) of adult patients, and provide volume sets used for specialized studies by trained physicians.
Technology
Employs a next-generation photon counting detector unit enabling images based on X-rays with different energy levels, capturing cross-sectional volume data sets for specialized studies; operates with conventional scan, helical scan, and volume/dynamic volume scan modes; supports high resolution and rapid image reconstruction.
Performance
Bench testing including phantom image quality evaluations showed equivalent or improved performance compared to the predicate device in measures such as contrast-to-noise ratio, CT number accuracy, uniformity, modulation transfer function, and low contrast detectability. Clinical images reviewed by certified radiologists confirmed diagnostic quality. Software verification and cybersecurity documentation were also submitted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/31/2024
7 months - 2
FDA Approval
6/20/2025
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