# K103424: Safire

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 22, 2011 after 365 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: 5 generations back to K013561 (2001). 10 ancestors in all.
2 later devices descend 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)
- K082220: Somatom Flash DS, Siemens Medical Solutions USA, Inc. (2008) Summary page 2.

## Most influential descendants
- K133646: Admire (2014), 1 descendant of its own
- K153360: Admire (2016), 0 descendants of its own

## Indications for use
SAFIRE is a CT reconstmuction software. The end user can choose to apply either SAFIRE or the weighted filter back-projection (WFSP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of SAFIRE can help to reduce radiation dose while maintaining Pixel noise, low contrast dletectability and high contrast resolution. Phantom irieasuremnents showed that high contrast resolution and pixel noise are equivalent between full dose WFBP images and reduced dose SAFIRE images. Additionally, SAFIRE can reduce spiral artifacts by using iterations going back and forth between image space and raw data space. A Model Observer evaluation showed that equivalent low contrast detectability can be achieved with 54% to 60% less dose using SAFIRE at highest noise reduction strength for thin (0.6 mm) reconstruction slices in simulated body and head phantoms for low contrast objects with different contrasts. Images reconstructed with SAFIRE are not intended to be evaluated with syngo Osten CT or syngo Calcium Scoring.

Source page: https://510kreport.com/device/K103424
Methodology: https://510kreport.com/methodology