# K113086: ACQA

- Pathway: 510(k) (Traditional)
- Applicant: Texas Medical Imaging Consultants
- Decided: Jan 13, 2012 after 87 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945512 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041543: GE Discovery ST, GE Healthcare (2004) Summary page 1.
- K032915: Advantage 4D Option, Ge Medical Systems, LLC (2003) Summary page 1.

## Indications for use
The ACQA system is a software on GE Advantage Windows workstation computers that allow the user to create averaged CT images for attenuation correction of the whole body or myocardial perfusion PET images, and to register CT images with myocardial perfusion PET images, and save registered CT images for attenuation correction of myocardial perfusion PET images. The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physicians read the original PET images.

Source page: https://510kreport.com/device/K113086
Methodology: https://510kreport.com/methodology