# K143294: Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: May 15, 2015 after 179 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: 8 generations back to K954355 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103480: Thoracic Vcar, Ge Medical Systems, LLC (2011) Summary page 4.
- K120910: Cardiq Xpress 2.0 with Snapshot Freeze Option Cardiq Xpress 2.0 Reveal, GE Medical Systems SCS (2012) Summary page 4.

## Indications for use
Adaptive Motion Correction (AMC) software is intended to be used as an adjunct to the current cardiac reconstruction methods in cases where motion of the coronary arteries creates artifacts. This software can be applied to these images, without additional dose to the patient, to enhance the visibility of the coronary arteries. 4D Airways Analysis is a post processing software that may be used in conjunction with chest CT images to provide automatic (semi-automatic) segmentation of the bronchial tree. This software may aid in the diagnosis and follow-up treatment of bronchial diseases.

Source page: https://510kreport.com/device/K143294
Methodology: https://510kreport.com/methodology