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Vista MR 2055 HP System and 2055 Upgrades

FDA 510(k)

Class II (US FDA 510(k))

510(k) K893739

by Philips Medical Systems (Cleveland), Inc.

Identifiers

510(k) Number
K893739 FDA 510(k)
FDA Product Code
LNH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vista MR 2055 HP System is a Nuclear Magnetic Resonance Imaging (MRI) device designed for diagnostic imaging. It generates detailed images of the human body using strong magnetic fields and radio waves, enabling radiologists to evaluate internal structures with high resolution. This system supports various MRI sequences and imaging modalities, including T1-weighted, T2-weighted, and gradient-echo techniques, to assess soft tissues, organs, and musculoskeletal systems. Its advanced hardware and software configurations allow for versatile applications in clinical radiology settings.

The Vista MR 2055 HP System is intended for use in clinical radiology departments and MRI-equipped facilities. It is a reusable, non-sterile device, though accessories or consumables may require sterilization depending on their contact with patients. The system operates within MRI-safe environments, adhering to strict electromagnetic compatibility and safety standards. Multiple model references and upgrades are included, ensuring compatibility with various imaging protocols and patient sizes. Authorized under FDA 510(k) clearance (K893739), this system is classified as a Class II medical device under the FDA’s regulatory framework.

Frequently asked questions

What is the Vista MR 2055 HP System used for?

The Vista MR 2055 HP System is designed for diagnostic imaging using Nuclear Magnetic Resonance (NMR) technology. It generates detailed images of the human body by leveraging strong magnetic fields and radio waves, enabling radiologists to evaluate internal structures with high resolution. This system is particularly useful for assessing soft tissues, organs, and musculoskeletal systems, supporting various MRI sequences like T1-weighted, T2-weighted, and gradient-echo techniques.

Is the Vista MR 2055 HP System reusable or single-use?

The Vista MR 2055 HP System is a reusable device. It is not intended for single-use and is designed for repeated use in clinical radiology departments. However, accessories or consumables that come into direct contact with patients may require sterilization to ensure patient safety and compliance with medical standards.

What types of imaging sequences does the Vista MR 2055 HP System support?

The system supports a variety of MRI sequences, including T1-weighted, T2-weighted, and gradient-echo techniques. These sequences are used to highlight different tissue properties, allowing radiologists to assess soft tissues, organs, and musculoskeletal systems with enhanced clarity and diagnostic precision.

Are there different model references or upgrades available for the Vista MR 2055 HP System?

Yes, the Vista MR 2055 HP System includes multiple model references and upgrades. These variations ensure compatibility with different imaging protocols and accommodate various patient sizes, enhancing the system’s versatility in clinical settings.

What safety standards does the Vista MR 2055 HP System adhere to?

The Vista MR 2055 HP System operates within MRI-safe environments, adhering to strict electromagnetic compatibility and safety standards. This ensures that the device can be used safely alongside other medical equipment and in environments where electromagnetic interference could pose risks.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES (K893675) — FDA 510(k ..., K893675 FDA 510(k) - VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES, K893739 FDA 510(k) - VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES, Vista Mr 2055 Hp System And 2055 Upgrades 510(k)… - FDA.report, Windows Vista - Wikipedia

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems (Cleveland), Inc.

Sources (1)

  • FDA 510(k) K893739 24 fields · synced Oct 6, 2026