# K142584: iMAR

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 16, 2015 after 123 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 K982349 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130901: Somatom Definition as Open, Siemens Medical Systems, Inc. (2014) Summary page 4.

## Indications for use
iMAR is Siemens’ iterative reconstruction software designed to reduce metal artifacts in CT images. It is a user-selected option, to be used with conventional reconstruction methods (WFBP or iterative reconstruction) on Siemens CT systems. The amount of metal artifact reduction and corresponding improvement in image quality depends on a number of factors including: composition and size of the metal object, patient size, anatomical location and clinical practice. It is recommended to perform reconstructions with iMAR enabled, in addition to conventional reconstruction without IMAR.

Source page: https://510kreport.com/device/K142584
Methodology: https://510kreport.com/methodology