De Novo · Granted
GrantedBrainSee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Darmiyan, Inc. · QWT Prognostic Assessment Software Of Mild Cognitive Impairment
Granted on Jan 11, 2024 as a new device type through De Novo after a 469-day review.
- Decided
- Jan 11, 2024
- Review
- 469 days
- Class
- Class II
- Product code
- QWT
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 QWT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All QWT devicesQWT Prognostic Assessment Software Of Mild Cognitive Impairment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QWT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QWT
Too few QWT 510(k)s in any year since 2007 to give a median.
Recalls per year · QWT
No recall names QWT since 2007.
Adverse event reports per year · QWT
No MAUDE report names QWT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
BrainSee is a software application indicated as a prognostic tool to aid in the clinical assessment of how likely patients aged between 55 and 95 years old who are diagnosed with amnestic mild cognitive impairment (aMCI) are to progress to clinical Alzheimer’s disease (AD)-dementia within 5 years of assessment. BrainSee analyzes inputs of brain magnetic resonance imaging (MRI), patient demographic information, and cognitive assessment scores to produce a…
Read the full statement (300 words)
BrainSee is a software application indicated as a prognostic tool to aid in the clinical assessment of how likely patients aged between 55 and 95 years old who are diagnosed with amnestic mild cognitive impairment (aMCI) are to progress to clinical Alzheimer’s disease (AD)-dementia within 5 years of assessment. BrainSee analyzes inputs of brain magnetic resonance imaging (MRI), patient demographic information, and cognitive assessment scores to produce a similarity score between 0 and 100 reflecting the degree of similarity between the patient and two reference populations of aMCI patients who either did not progress to clinical AD-dementia within 5 years (non-converters) or progressed to clinical AD-dementia within 5 years (converters). Clinical AD-dementia is defined as probable Alzheimer’s disease established according to the National Institute of Neurological and Communicative Disorders and Stroke – Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer’s Criteria.
• Similarity scores less than 50 indicate that a patient’s inputs are more similar to those of the non-converter population.
• Similarity scores greater than 50 indicate that a patient’s inputs are more similar to those of the converter population.
• Patients with a similarity score close to 50 have inputs that are similar to both the converter and non-converter aMCI patient populations used to develop and train the BrainSee device.
The similarity score output is provided along with information to assist in the interpretation of the output to aid in evaluating the prognosis of patients diagnosed with aMCI to progress to clinical AD-dementia within 5 years.
The BrainSee analysis is intended to provide supplemental information for interpretation in conjunction with a standard neurological assessment. Patient management decisions should not be made solely on the results of the BrainSee analysis. BrainSee is not indicated as a stand-alone diagnostic or prognostic tool. BrainSee should not be used to diagnose aMCI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220066 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220066: BrainSee.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220066
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026