# K180394: BrightMatter Plan 1.6.0

- Pathway: 510(k) (Traditional)
- Applicant: Synaptive Medical, Inc.
- Decided: Mar 9, 2018 after 24 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: 7 generations back to K983410 (1999). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140337: Brightmatter Planning Software, Synaptive Medical, Inc. (2014) Summary page 4.

## Indications for use
BrightMatter Plan is indicated for: Viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and image segmentation where the output can be used for image guided surgery. Planning and simulation of cranial surgical procedures. Reviewing of existing treatment plans. Typical users of the software are medical professionals, including but not limited to surgeons and radiologists.

Source page: https://510kreport.com/device/K180394
Methodology: https://510kreport.com/methodology