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READY VIEW

by Ge Healthcare (Ge Medical Systems Scs) 2 variants

510(k) K110573

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110573 Date3 May 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2241-2013 FDA Class II initiated 27 Mar 2012

    GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

READY VIEW is a Class II X-ray system manufactured by GE Healthcare (Ge Medical Systems Scs). It is classified as a System, Image Processing, Radiological within the LLZ classification, which encompasses advanced image processing and PACS-adjacent software.

The device is used in radiology and was first cleared by the FDA in 2011. It is intended for use in clinical settings and is regulated under FDA 510(k) clearance. The device is not specified as single-use or reusable, and no specific storage or MRI safety information is provided.

Other devices from Ge Healthcare (Ge Medical Systems, LLC)

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the READY VIEW X-ray system used for?

    The READY VIEW is a Class II X-ray system manufactured by GE Healthcare. It is intended for use in clinical settings, specifically within radiology, and functions as a system for image processing and radiological software.

  • When was the READY VIEW X-ray system first cleared by the FDA?

    The READY VIEW X-ray system was first cleared by the FDA in 2011. The device was reviewed and received clearance on May 3, 2011.

  • What is the regulatory classification of the READY VIEW X-ray system?

    The READY VIEW is classified as a Class II medical device. It is specifically categorized as a System, Image Processing, Radiological within the LLZ classification.

  • What is the advisory committee review for the READY VIEW X-ray system?

    The READY VIEW X-ray system was reviewed by the Radiology (RA) advisory committee. The review was part of the FDA's traditional 510(k) clearance process.