Device Information
The medical device is a Magnetic Resonance Diagnostic Device, classified as Class II, with the device name Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR.
Purpose
The device is intended for diagnostic imaging of anatomic structures of the head or body, including functional imaging and angiography.
Indications for Use
The device is indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images. It is capable of non-contrast enhanced imaging and can be used with contrast agents depending on the region of interest.
Labeling and Compliance
The device labeling must be truthful and not misleading, and the manufacturer must comply with all applicable FDA regulations, including labeling requirements (21 CFR Part 801) and good manufacturing practice requirements (21 CFR Part 820).
Conclusion
This summary provides an overview of the medical device user manual, highlighting the device’s classification, purpose, indications for use, and labeling and compliance requirements.
Manual:
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