# K113483: Iterative Reconstruction Technique Software Application

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare (Cleveland)
- Decided: Sep 26, 2012 after 308 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 K930090 (1993). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060937: Brilliance Volume, Philips Medical Systems (Cleveland), Inc. (2006) Summary page 1.

## Most influential descendants
- K123576: Imr Software Application (2013), 0 descendants of its own

## Indications for use
The Philips Iterative Reconstruction Technique (IRT) Software Application is intended to reconstruct raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection reconstruction. Resulting (IRT) images are to be used to supplement conventional Filtered Back Projection images to aid the physician in diagnosis; they are not to be used as the sole basis for diagnosis.

Source page: https://510kreport.com/device/K113483
Methodology: https://510kreport.com/methodology