510(k) · Cleared
ClearedBrainSpec Core™ Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainspec, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 14, 2023 as substantially equivalent to K120315 (Siemens Medical Solutions USA, Inc., 2012) after a 230-day review. Its family tree reaches back 9 generations to 1997. 2 of the 23 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 14, 2023
- Review
- 230 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K971684 (1997). 22 ancestors in all, the oldest K970852 (1997). No later device cites it as a predicate yet. 2 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations between
- 3 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 2 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 1 generation backK120315 Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi…Siemens Medical Solutions USA, Inc. · 2012
- This deviceK230856 BrainSpec Core™ SoftwareBrainspec, Inc. · 2023
Show all 9 generations
- Root · 9 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 7 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 5 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 4 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 3 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 2 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 1 generation backK120315 Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi…Siemens Medical Solutions USA, Inc. · 2012
- This deviceK230856 BrainSpec Core™ SoftwareBrainspec, Inc. · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −8 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −7 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −6 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −5 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −4 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −3 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −2 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −1 | K120315 | Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi, Syngo.MR… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| 0 (this device) | K230856 | BrainSpec Core™ Software | Brainspec, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K120315 | Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi, Syngo.MR Spectro…Summary page 6…substantially equivalent to the predicate device shown in Table 1. Trade Name Clearance Claim of Equivalence for: 510(k) holder Siemens Syngo K120315 Primary Predicate Siemens Table 1: Predicate devices Indications for Use:… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 22 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K120315.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
BrainSpec Core™ software is a post-processing application to analyze and evaluate MR (magnetic resonance) spectroscopy data. It provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data to support the diagnostic process. BrainSpec Core™ software includes the possibility of an integrated reading of MR images and spectroscopy data for spectroscopy exams and focuses on ease-of-use by reducing complexity. A fit…
Read the full statement (146 words)
BrainSpec Core™ software is a post-processing application to analyze and evaluate MR (magnetic resonance) spectroscopy data. It provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data to support the diagnostic process. BrainSpec Core™ software includes the possibility of an integrated reading of MR images and spectroscopy data for spectroscopy exams and focuses on ease-of-use by reducing complexity.
A fit algorithm reduces the need for manual data processing and offers the user reproducible evaluation results. When interpreted by a trained physician, these results provide information that may assist in diagnosis.
The post-processing fits and displays spectra and provides intuitive representations of the metabolic profile. The calculation and display of pre-defined results such as spectra, spectral maps, and metabolite images is provided. Interactive reading of spectroscopy exams is supported by side-by-side display of MR images and spectroscopy results, and synchronized display.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230856 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230856: BrainSpec Core™ Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230856
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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