510(k) · Cleared
ClearedBriefCase-Quantification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aidoc Medical, Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Nov 13, 2023 as substantially equivalent to K211222 (Qure.Ai Technologies, 2021) after a 123-day review. Its family tree reaches back 5 generations to 2006.
- Decided
- Nov 13, 2023
- Review
- 123 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K061855 (2006). No later device cites it as a predicate yet.
- Root · 5 generations backK061855 NeuroquantCortechs Labs, Inc. · 2006
- 4 generations backK161148 icobrainIcometrix · 2016
- 3 generations backK180326 icobrainIcometrix · 2018
- 2 generations backK181939 icobrainIcometrix NV · 2018
- 1 generation backK211222 qER-QuantQure.Ai Technologies · 2021
- This deviceK232083 BriefCase-QuantificationAidoc Medical, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K211222 | qER-QuantSummary page 4…anagement and processing system Regulatory Class: Class II Product Code: QIH (21 CFR 892.2050) Primary Predicate Device: qER-Quant (K211222) Device Description BriefCase-Quantification is a radiological image management and processing device. The software consists of… | 2021 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K211222.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 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 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
BriefCase-Quantification of Midline Shift (MLS) is a radiological image management and processing system software intended for automatic measurement of brain midline shift in non-contrast head CT (NCCT) images, in adults or transitional adolescents aged 18 years and older. The device is intended to assist appropriately trained medical specialists by providing the user with an automated current manual process of measuring midline shift. The device…
Read the full statement (157 words)
BriefCase-Quantification of Midline Shift (MLS) is a radiological image management and processing system software intended for automatic measurement of brain midline shift in non-contrast head CT (NCCT) images, in adults or transitional adolescents aged 18 years and older.
The device is intended to assist appropriately trained medical specialists by providing the user with an automated current manual process of measuring midline shift.
The device provides midline shift measurement from NCCT images acquired at a single time point, and can additionally provide an output with comparative analysis of two or more images that were acquired in the same individual at multiple time points.
The device does not alter the original medical image and is not intended to be used as a diagnostic device. The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. Clinicians are responsible for viewing full images per the standard of care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232083 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232083: BriefCase-Quantification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232083
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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