510(k) · Cleared
ClearedData Analysis Facilitation Suite (DAFS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voronoi Health Analytics Incorporated · QIH Automated Radiological Image Processing Software
Cleared on Mar 16, 2026 as substantially equivalent to K223556 (Medical IP Co., Ltd., 2023) after a 96-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Mar 16, 2026
- Review
- 96 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K954355 (1995). 21 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 10 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 6 generations between
- 3 generations backK120648 Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2012
- 2 generations backK130542 Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2013
- 1 generation backK223556 DeepCatchMedical IP Co., Ltd. · 2023
- This deviceK253944 Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated · 2026
Show all 10 generations
- Root · 10 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 9 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 8 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 7 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 6 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 5 generations backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- 4 generations backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- 3 generations backK120648 Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2012
- 2 generations backK130542 Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2013
- 1 generation backK223556 DeepCatchMedical IP Co., Ltd. · 2023
- This deviceK253944 Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −9 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −8 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −7 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −6 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −5 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| −4 | K083227 | Vida Pulmonary Workstation 2 (PW2) | Vida Diagnostics, Inc. | 2008 | — |
| −3 | K120648 | Synapse 3D Lung and Abdomen Analysis | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| −2 | K130542 | Synapse 3D Lung and Abdomen Analysis | Fujifilm Medical System U.S.A., Inc. | 2013 | — |
| −1 | K223556 | DeepCatch | Medical IP Co., Ltd. | 2023 | — |
| 0 (this device) | K253944 | Data Analysis Facilitation Suite (DAFS) | Voronoi Health Analytics Incorporated | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 23.6 · 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 |
|---|---|---|---|
| * | K223556 | DeepCatchSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K223556 1 1 DeepCatch 1 1 QIH Device Descrip… | 2023 |
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 31 years and passes through 10 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 21 ancestors has a recall of any class.
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. 2026, 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?
OAFS is a software-only medical device intended for use by trained healthcare professionals for the automated segmentation, visualization, and quantitative analysis of anatomical structures in computed tomography (CT) images. The software processes DICOM Part 10 formatted CT image data to identify, segment anatomical structures, including body composition tissues and internal organs and annotate DICOM slices by anatomical landmarks. The device provides…
Read the full statement (129 words)
OAFS is a software-only medical device intended for use by trained healthcare professionals for the automated segmentation, visualization, and quantitative analysis of anatomical structures in computed tomography (CT) images.
The software processes DICOM Part 10 formatted CT image data to identify, segment anatomical structures, including body composition tissues and internal organs and annotate DICOM slices by anatomical landmarks. The device provides quantitative measurements of these structures, including area, volume, and intensity values, and displays 2D and 3D visual representations.
The software provides tools for visualization, review, and manual editing of segmentation and slice annotation results and associated measurements.
OAFS is intended for use as an adjunct to clinical assessment. The device does not provide diagnostic interpretation, and all results must be reviewed and confirmed by a qualified healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253944 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253944: Data Analysis Facilitation Suite (DAFS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253944
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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