# K133640: ASIR-V

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Mar 25, 2014 after 118 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K013561 (2001). 9 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103489: GE Veo Reconstruction Option, General Electric Co. (2011) Summary page 1.
- K093581: Discovery Model CT590 RT and Optima Model CT580 CT Systems, Ge Medical Systems, LLC (2011) Summary page 1.

## Most influential descendants
- K183202: Deep Learning Image Reconstruction (2019), 8 descendants of its own
- K213999: Deep Learning Image Reconstruction (2022), 2 descendants of its own
- K193170: Deep Learning Image Reconstruction (2019), 1 descendant of its own
- K253686: True Definition DL (2026), 0 descendants of its own
- K230807: Deep Learning Image Reconstruction (2023), 0 descendants of its own

## Indications for use
The ASiR-V Reconstruction Option is intended to produce cross-sectional images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial, Helical (Volumetric), and Cardiac acquisitions for all ages. When used, it allows for an alternate reconstruction method designed to reduce image noise and streak artifact, increase resolution and improve low contrast detectability in images produced using raw Computed Tomography data from the GE CT scanner. The ASiR-V Reconstruction Option can be used to reduce noise in images and also to reduce the dose required for diagnostic CT imaging, including scans of the head, chest, heart, abdomen and pelvis. The ASiR-V Reconstruction Option may also improve the image quality of low dose non-diagnostic Filtered Back Projection images such that they become diagnostic. ASiR-V reconstruction option is for use with the GE CT Scanners.

Source page: https://510kreport.com/device/K133640
Methodology: https://510kreport.com/methodology