# K022919: Smart Breath Respiratory Compensation Option

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Sep 19, 2002 after 15 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: 4 generations back to K945512 (1995). 4 ancestors in all.
217 later devices descend from it; 1 cites it directly.
1 of 222 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020929: Smartscore 3.5; Smartscore 4.0; Smartscore 4.5, GE Medical Systems (2002) Summary page 2.

## Most influential descendants
- K032915: Advantage 4D Option (2003), 216 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K101749: Syngo Trued Software (2010), 76 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own

## Indications for use
Smart Breath respiratory compensation option is a non-invasive software / hardware options that can be used to improve clinical images by reducing organ and tissue motion related to respiratory motion from patient breathing during a CT acquisition. The software will allow the user to retrospectively define the best respiratory phase from an image quality standpoint, and then will group images by the phase selected.

Source page: https://510kreport.com/device/K022919
Methodology: https://510kreport.com/methodology