Ready View

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K113456 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5T Open recall

  Class II

  FDA 510(k) K132376 Active Cleared 15 Nov 2013

• SIGNA Creator, SIGNA Explorer Open recall

  Class II

  FDA 510(k) K143251 Active Cleared 4 Feb 2015

• Optima MR450W

  Class II

  FDA 510(k) K123522 Active Cleared 13 Mar 2013

• SIGNA Architect Open recall

  Class II

  CE/MDR FDA 510(k) K202966 Active Cleared 13 Nov 2020 +1authorizations

• SIGNA Hero Open recall

  Class II

  CE/MDR FDA 510(k) K213668 Active Cleared 20 Jan 2022

• Ready View

  Class II

  FDA 510(k) K110573 Active Cleared 3 May 2011

See all devices from Ge Healthcare (Ge Medical Systems, LLC) →

• What types of imaging modalities can the Ready View Radiographic Image Viewer support for real-time viewing and analysis?

  The Ready View is specifically designed to support real-time viewing and analysis of radiographic images from X-ray, CT scans, and other imaging modalities. Its high-resolution display and adjustable contrast/brightness settings are optimized to enhance diagnostic clarity across these modalities, making it suitable for radiology departments and clinical imaging environments.

• Is the Ready View intended for single-use or reusable applications in a clinical setting?

  The Ready View is supplied as a reusable medical instrument, meaning it is designed for repeated use within radiology departments, hospitals, and clinical imaging settings. Reusability is a key aspect of its design, though proper cleaning, maintenance, and storage per manufacturer guidelines are required to ensure performance and hygiene.

• How should the Ready View be stored to maintain its functionality and image quality?

  The Ready View must be stored and maintained according to the manufacturer’s guidelines to preserve its performance and ensure accurate image fidelity. While specific storage conditions aren’t detailed here, typical practices for reusable medical imaging devices—such as protection from dust, moisture, and physical damage—are implied. Always refer to Ge Healthcare’s instructions for precise storage protocols.

• What regulatory pathways does the Ready View follow, and what does that mean for its use in hospitals?

  The Ready View follows the FDA’s Special 510(k) pathway (K113456) and complies with MDR (Medical Device Regulation) requirements. This means its design was evaluated as substantially equivalent to a predicate device and meets EU regulatory standards. Clinically, this indicates it has undergone rigorous review for safety and performance, ensuring it can be reliably integrated into radiology workflows in hospitals and imaging centers.

• Can the Ready View be used in an MRI environment, and if so, under what conditions?

  Yes, the Ready View is MRI Conditional as specified by the manufacturer. This means it can be safely used in an MRI environment under the conditions outlined in Ge Healthcare’s documentation, such as specific distance requirements from the MRI magnet and compliance with electromagnetic interference guidelines. Always follow the manufacturer’s instructions to avoid compromising MRI safety or device performance.