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 8, 2023 as substantially equivalent to K221100 (Viz. Ai, Inc., 2022) after a 254-day review. Its family tree reaches back 9 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 8, 2023
- Review
- 254 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K945512 (1995). 18 ancestors in all, the oldest K945428 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 5 generations between
- 3 generations backK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- 2 generations backK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- 1 generation backK221100 Viz RV/LVViz. Ai, Inc. · 2022
- This deviceK230534 BriefCase-QuantificationAidoc Medical, Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK241112 BriefCase-QuantificationAidoc Medical, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK243779 Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health · 2025
- Descendant · 2 generations on · 0 of its ownK242203 BriefCase-QuantificationAidoc Medical, Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 8 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 7 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 6 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 5 generations backK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
- 4 generations backK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
- 3 generations backK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- 2 generations backK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- 1 generation backK221100 Viz RV/LVViz. Ai, Inc. · 2022
- This deviceK230534 BriefCase-QuantificationAidoc Medical, Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −8 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −7 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −6 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −5 | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
| −4 | K083446 | Cardiac Function Analysis, Calcium Scoring | Ziosoft, Inc. | 2009 | — |
| −3 | K111373 | CT42 Cardiac Computed Tomography (CT) Software | Circle Cardiovascular Imaging, Inc. | 2011 | — |
| −2 | K203256 | Imbio RV/LV Software | Imbio, LLC | 2021 | — |
| −1 | K221100 | Viz RV/LV | Viz. Ai, Inc. | 2022 | — |
| 0 (this device) | K230534 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2023 | — |
| +1 | K241112 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2024 | — |
| +1 | K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) | BunkerHill Health | 2025 | — |
| +2 | K242203 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K221100 | Viz RV/LVSummary page 4…egulatory Class: Class II Product Code: QIH (21 C.F.R. 892.2050) Primary Predicate Device: Viz RV/LV (K221100) Reference Device: AI-Rad Companion (Cardiovascular)(K183268) Device Description BriefCase-Quant… | 2022 |
| † | K183268 | AI-Rad Companion (Cardiovascular) | 2019 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K241112 (Aidoc Medical, Ltd., 2024) has gone furthest, with 1 descendant of its own.
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 is a radiological image management and processing system software indicated for use in the analysis of CT exams with contrast, that include the abdominal aorta, in adults or transitional adolescents aged 18 and older. The device is intended to assist appropriately trained medical specialists by providing the user with the maximum abdominal aortic axial diameter measurement of cases that include the abdominal aorta (M-AbdAo).…
Read the full statement (147 words)
BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of CT exams with contrast, that include the abdominal aorta, in adults or transitional adolescents aged 18 and older.
The device is intended to assist appropriately trained medical specialists by providing the user with the maximum abdominal aortic axial diameter measurement of cases that include the abdominal aorta (M-AbdAo). BriefCase-Quantification is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate post-operative aortas.
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. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care.
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/K230534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230534: BriefCase-Quantification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230534
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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