# K140337: Brightmatter Planning Software

- Pathway: 510(k) (Traditional)
- Applicant: Synaptive Medical, Inc.
- Decided: Jun 2, 2014 after 112 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 K983410 (1999). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073449: Surgicase, Materialise NV (2008) Summary page 1.
- K113732: Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine), Brainlab AG (2012) Summary page 2.

## Most influential descendants
- K180394: BrightMatter Plan 1.6.0 (2018), 0 descendants of its own

## Indications for use
BrightMatter Planning's indications for use are the 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. BrightMatter Planning can be used for planning and simulation of cranial surgical procedures and 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/K140337
Methodology: https://510kreport.com/methodology