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The MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

Identical to the AIRIS and MRP-7000 with Version 4.0 Operating System software (Cf. K971279), and the AIRIS and MRP-7000 with Version 4.0D Operating System software as described in a memo-to-file document, dated September 22, 1997.

The AIRIS Operating System Software is revised to Version 5.0 to increase the clinical utility of the AIRIS in the stationary configuration. The MRP-7000 Operating System Software is revised to Version 5.0 to increase the clinical utility of the MRP-7000 in both stationary and mobile configurations.

Version 5.0 Operating System revisions include additional image acquisition sequences (3D SG TOF MRA, high SNR MR Fluoroscopy sequence, 3D FSE/FIR sequences, additional T1-weighted 2D FSE sequence, and addition of 2D RF-spoiled SARGE sequence). Image acquisition sequence enhancements include improvement in fat suppression for STIR and Fast STIR, addition of Dual Slice function to 2D GE/ GR, addition of small FOV FSE sequence, addition of rephase to FIR sequence, addition of ECG-gating to 2D SG sequence (currently available only for 2D SE. GE and GR sequences), and addition of off-resonance MTC to 3D TOF, SE, GE and GR sequences (currently only on-resonance MTC available). A raw data filter is additionally available to reduce truncation artifacts.

This submission describes a software update (Version 5.0 Operating System Software) for existing Hitachi AIRIS and MRP-7000 Magnetic Resonance Diagnostic Devices. The 510(k) summary indicates that the device has the "same intended use" and "identical technological characteristics" as the predicate devices (Hitachi AIRIS with Version 4.0 Operating System Software and Hitachi MRP-7000 with Version 4.0 Operating System Software).

Therefore, the submission does not contain information about acceptance criteria or a dedicated study proving the device meets specific performance criteria. The substantial equivalence relies on the fact that the updated software introduces new imaging sequences and enhancements but operates within the established principles and capabilities of MR imaging, as demonstrated by the predicate devices.

Specifically, the document states:

• FUNCTION: "Identical to the AIRIS and MRP-7000 with Version 4.0 Operating System software (Cf. K971279)..."
• DEVICE TECHNOLOGICAL CHARACTERISTICS: "Identical to the Predicate Device."
• DEVICE INTENDED USE: The description of the intended use is broad and consistent with general MR imaging devices.

Because this is a submission for a software update deemed substantially equivalent to a predicate device, a new clinical performance study with specific acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness studies (MRMC or standalone) is not typically required or included in such a 510(k) summary. The FDA's 510(k) clearance process for devices like this primarily focuses on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, rather than requiring a detailed de novo performance study.

Therefore, I cannot provide the requested table or specific study details because they are not present in the provided 510(k) summary document. The provided document focuses on describing the device, its functions, scientific concepts, and receiving FDA clearance based on substantial equivalence.

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