Search Results

The MRI system is indicated for use as a diagnostic imaging modality that produces crosssectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. In addition, this system supports non-contrast MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

• . Proton density (PD) (also called hydrogen density)
• Spin-lattice relaxation time (T1) .
• . Spin-spin relaxation time (T2)
• Flow dynamics .
• Chemical shift .

Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

The Vantage Titan HSR (Model MRT-1504/A5) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan HSR uses the same magnet as the existing Vantage Titan (K080038). It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Titan HSR provides the maximum field of view of 55 x 55 x 55 cm.

The provided text describes a 510(k) premarket notification for the Toshiba Vantage Titan HSR MRI system, focusing on its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, device performance metrics, or a study designed to prove the device meets these criteria in the manner requested.

The document details safety parameters and imaging performance but only states:

• Imaging Performance Parameters: "No change from the previous predicate submission (K080038)."
• Testing: "Testing was done in accordance with applicable recognized consensus standards as listed below. Additionally, human volunteer studies (in Japan) were conducted to verify imaging performance."

This indicates that the primary method for demonstrating device effectiveness and safety was through showing substantial equivalence to an existing device, rather than through a new, specific performance study with defined acceptance criteria. The "human volunteer studies" are mentioned very generally without details on design, metrics, or results.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance through substantial equivalence, hardware/software changes, and safety standards, not on a detailed clinical or performance study with acceptance criteria and results.

Ask a specific question about this device