510(k) · Cleared
ClearedBrightMatter Plan 1.6.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synaptive Medical, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 9, 2018 as substantially equivalent to K140337 (Synaptive Medical, Inc., 2014) after a 24-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Mar 9, 2018
- Review
- 24 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K983410 (1999). 16 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 7 generations backK983410 @ TargetBrainlab AG · 1999
- 6 generations backK020631 IPLANBrainlab AG · 2002
- 5 generations backK041703 IPLAN!Brainlab AG · 2004
- 4 generations backK053127 IPLANBrainlab AG · 2006
- 3 generations backK101627 IPLANBrainlab AG · 2011
- 2 generations backK113732 Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan…Brainlab AG · 2012
- 1 generation backK140337 Brightmatter Planning SoftwareSynaptive Medical, Inc. · 2014
- This deviceK180394 BrightMatter Plan 1.6.0Synaptive Medical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K983410 | @ Target | Brainlab AG | 1999 | — |
| −6 | K020631 | IPLAN | Brainlab AG | 2002 | — |
| −5 | K041703 | IPLAN! | Brainlab AG | 2004 | — |
| −4 | K053127 | IPLAN | Brainlab AG | 2006 | — |
| −3 | K101627 | IPLAN | Brainlab AG | 2011 | — |
| −2 | K113732 | Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View… | Brainlab AG | 2012 | — |
| −1 | K140337 | Brightmatter Planning Software | Synaptive Medical, Inc. | 2014 | — |
| 0 (this device) | K180394 | BrightMatter Plan 1.6.0 | Synaptive Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140337 | Brightmatter Planning SoftwareSummary page 4…the following device: Trade name Manufacturer 510(k) Number Date Cleared BrightMatter Planning Synaptive Medical K140337 June 02, 2014 Software 1.0 Inc. Device Description BrightMatter Plan is a treatment planning… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 16 ancestors has a recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180394: BrightMatter Plan 1.6.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180394
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026