# K093234: Integrated Registration

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Oct 30, 2009 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K941223 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010336: Advantage Windows CT/Pet Fusion, Ge Medical Systems, Inc. (2001)
- K983256: Advantage Windows (AW) Fusion, GE Medical Systems (1998) Summary page 1.
- K022310: Advantage Windows X-Ray/MR Fusion, Ge Medical Systems, Inc. (2002) Summary page 1.

## Indications for use
INTEGRATED REGISTRATION provides easy means for comparison of three-dimensional (3D) images from Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Emission Tomography (PET or SPECT) and X-Ray Angiography (XA). To help physicians in diagnostic radiology or therapy planning, INTEGRATED REGISTRATION allows 3D registration between volumetric acquisitions that may come from the same acquisition modality or from different acquisition modalities.

Source page: https://510kreport.com/device/K093234
Methodology: https://510kreport.com/methodology