# K163250: Longitudinal Brain Imaging (LoBI) application

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: May 11, 2017 after 174 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: 13 generations back to K971684 (1997). 129 ancestors in all.
No later device cites it as a predicate yet.
3 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151353: syngo.MR Neurology, syngo.MR Oncology, Siemens Medical Solutions USA, Inc. (2015) Summary page 6.
- K101749: Syngo Trued Software, Siemens Medical Solutions (2010) Summary page 6.

## Indications for use
The Longitudinal Brain Imaging (LoBI) is a post-processing application to be used for viewing and evaluating neurological images provided by a magnetic resonance diagnostic device. The LoBI application is intended for viewing, manipulation, 3D- visualization and comparison of medical imaging and/or multiple time-points. The LoBI application enables visualization of information that would otherwise have to be visually compared disjointedly. The LoBI application provides analysis tools to help the user assess, and document changes in diagnostic and follow-up examinations. The LoBI application is designed to support the workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The physician retains the ultimate responsibility for making the final diagnosis and treatment decision.

Source page: https://510kreport.com/device/K163250
Methodology: https://510kreport.com/methodology