# K110573: Ready View

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare (Ge Medical Systems Scs)
- Decided: May 3, 2011 after 63 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K871859 (1987). 9 ancestors in all.
38 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960265: Advantage Windows with Functool Option, GE Medical Systems (1996) Summary page 2.
- K041521: Volume Viewer Plus, General Electric Medical Systems (2004) Summary page 2.

## Most influential descendants
- K121762: Cardiac VX (2013), 21 descendants of its own
- K140587: MR-CT Vva (2015), 19 descendants of its own
- K120361: Synapse 3D Base Tools (2012), 13 descendants of its own
- K203103: Synapse 3D, Synapse 3D Base Tools v6.1 (2021), 5 descendants of its own
- K191125: ADAS 3D (2020), 5 descendants of its own

## Recalls of this device
- Mar 27, 2012 · Class II · Z-2241-2013: 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.

## Indications for use
READY View is an image analysis software that allows the user to process dynamic or functional volumetric data and to generate maps that display changes in image intensity over time, echo time, b-value (Diffusion imaging) and frequency (Spectroscopy). The combination of acquired images, reconstructed images, calculated parametric images, tissue segmentation, annotations and measurement performed by the clinician allows multi-parametric analysis and may provide clinically relevant information for diagnosis.

Source page: https://510kreport.com/device/K110573
Methodology: https://510kreport.com/methodology