# K233660: nCommand Lite System

- Pathway: 510(k) (Traditional)
- Applicant: Ionic Health
- Decided: Mar 18, 2024 after 124 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K971684 (1997). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150193: Customer Remote Console (CRC), Ge Medical Systems, LLC (2015) Summary page 6.
- K052423: Magnetom Systems with Syngo Expert - I Option, Siemens Medi Cal Solutions, Inc. (2006) Summary page 4.
- K061449: Syngo Expert-1, Siemens Medical Solution (2006) Summary page 6.

## Indications for use
The nCommand Lite system allows remote access for viewing/review of images as well as the ability to remotely provide real-time guidance to the licensed technologist operating a compatible MRI, CT, and PET-CT scanner. This access must be granted by the local licensed technologist operating the system. The remote access is only available for systems supporting remote connectivity capability. Images reviewed remotely are not for diagnostic use.

Source page: https://510kreport.com/device/K233660
Methodology: https://510kreport.com/methodology