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Imaging of: The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.] -Fluid Visualization -2D/3D Imaging Additional indications for v3.1, v3.2, & v3.3 (only) - MR Angiography/MR Vascular Imaging - Additional indication for v3.2 & v3.3 (only) - Water/Fat Imaging - Additional indication for v3.3 {only} Perfusion/Diffusion Imaging -

Versions v3.0/v3.1/v3.2/v3.3 software are a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images. The four versions have the same base software features with certain additional features available in each subsequent version (see Comparison Table, Appendix B, for detailed description). A brief description follows: - v3.0: Based on v2.5 (K990260) with MR Angio and FASE sequences removed - v3.1: Based on v2.5 (K990260) - v3.2: Based on v2.6 (K990260) - v3.3: Based on v2.6 (K990260) with addition of Perfusion/Diffusion imaging

This 510(k) premarket notification describes an upgrade to an existing Magnetic Resonance Diagnostic Device, the OPART™ (Model MRT-600), to software versions v3.0, v3.1, v3.2, and v3.3, along with optional hardware items. The core of this submission is to demonstrate substantial equivalence to previously cleared versions and to justify new functionalities and increased safety parameters.

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1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on safety parameters and imaging performance. The "acceptance criteria" appear to be specified maximums for safety and a general "specification volume" for imaging. The "reported device performance" is essentially that the device operates within these stated limits and produces sample images.

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Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy.

Version 3.1 software consists of two model upgrades to the FLEXART™ system. The MRT-50GP/E2 (Flexart™) includes such new applicational features as FastASE, QuadScan and MR Fluoroscopy for scanning and MSOFT and PASTA for fat supression. The MRT-50GP/H1 (Flexart™/Hyper) increases the gradient field strength over that of the Flexart™ .

This 510(k) summary describes upgrades to an MRI system (FLEXART™ V3.1), focusing on improvements in hardware and software. It primarily discusses safety parameters and imaging performance in the context of demonstrating substantial equivalence to a previously cleared device. Due to the nature of this submission (upgrades to an existing MRI system for improved image quality and functionality, rather than a novel AI/CAD device), many of the specific questions regarding AI device evaluation (e.g., acceptance criteria for diagnostic performance metrics, human reader studies, ground truth establishment) are not directly applicable or reported in this document.

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Analysis of Acceptance Criteria and Device Performance Study (K962138)

This submission (K962138) concerns upgrades to an existing Magnetic Resonance Device (FLEXART™ V3.1). The primary goal of the submission is to demonstrate substantial equivalence to a previously cleared device (K933018, FLEXART™) by showing that the upgrades improve performance without raising new questions of safety or efficacy.

Therefore, the "acceptance criteria" and "device performance" in this context are focused on safety parameters and qualitative imaging performance improvements rather than quantitative diagnostic accuracy metrics typically seen for AI/CAD products.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an upgrade to an existing MRI system, the "acceptance criteria" are implicitly tied to maintaining or improving upon the safety and image quality of the predicate device, and demonstrating conformance with consensus standards.

• Rate of change of magnetic field (τ=1000ms) compliant and below IEC standard.
• Max RF power deposition compliant.
• Acoustic Noise levels within acceptable limits (below 100 dB(A) for patient-observed levels). | MRT-50GP/E2:
• Max static field strength: 0.5 T (Same as predicate)
• Rate of change of magnetic field: 11 T/sec (Same as predicate)
• Max RF power deposition:

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