# K123576: Imr Software Application

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare (Cleveland)
- Decided: Jun 7, 2013 after 199 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: 7 generations back to K930090 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113483: Iterative Reconstruction Technique Software Application, Philips Healthcare (Cleveland) (2012) Summary page 1.
- K060937: Brilliance Volume, Philips Medical Systems (Cleveland), Inc. (2006) Summary page 2.

## Indications for use
The IMR reconstruction feature is intended as an alternative to standard reconstruction methods (filtered back projection) for the reconstruction of CT scanner data to produce diagnostic images. The IMR reconstruction feature is designed to reduce image noise, increase high-contrast spatial resolution, and improve low contrast detectability. IMR is designed to reduce dose required for diagnostic CT imaging. Image quality improvements and dose reduction depend on the clinical task, patient size, anatomical location, and clinical practice. IMR images will be used by a trained medical professional for diagnosis of clinical conditions in patients, including pediatrics and adults, who have been prescribed a CT scan as part of their clinical care

Source page: https://510kreport.com/device/K123576
Methodology: https://510kreport.com/methodology