# K153360: Admire

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Jun 29, 2016 after 222 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 K013561 (2001). 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)
- K133646: Admire, Siemens Medical Systems, Inc. (2014) Summary page 5.

## Indications for use
ADMIRE is a CT reconstruction software. The end user can choose to apply either ADMIRE or the weighted filter back-projection (WFBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ADMIRE can help to reduce radiation dose while maintaining pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution is equivalent or improved and pixel noise is equivalent between full dose WFBP images and reduced dose ADMIRE images. Additionally, ADMIRE can reduce spiral artifacts by using iterations going back and forth between image space and raw data space. Images reconstructed with ADMIRE are not intended to be evaluated with syngo Osteo CT or syngo Calcium Scoring.

Source page: https://510kreport.com/device/K153360
Methodology: https://510kreport.com/methodology