510(k) · Cleared
ClearedDeepCatch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical IP Co., Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Jun 16, 2023 as substantially equivalent to K191026 (Medical IP Co., Ltd., 2019) and 1 other predicate after a 200-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it.
- Decided
- Jun 16, 2023
- Review
- 200 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K954355 (1995). 20 ancestors in all, the oldest K924810 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 5 generations between
- 3 generations backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- 2 generations backK120648 Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2012
- 1 generation backK130542 Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2013
- This deviceK223556 DeepCatchMedical IP Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK253944 Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated · 2026
Show all 9 generations
- Root · 9 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 8 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 7 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 6 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 5 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 4 generations backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- 3 generations backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- 2 generations backK120648 Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2012
- 1 generation backK130542 Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2013
- This deviceK223556 DeepCatchMedical IP Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −8 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −7 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −6 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −5 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −4 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| −3 | K083227 | Vida Pulmonary Workstation 2 (PW2) | Vida Diagnostics, Inc. | 2008 | — |
| −2 | K120648 | Synapse 3D Lung and Abdomen Analysis | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| −1 | K130542 | Synapse 3D Lung and Abdomen Analysis | Fujifilm Medical System U.S.A., Inc. | 2013 | — |
| 0 (this device) | K223556 | DeepCatch | Medical IP Co., Ltd. | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K191026 | Medip ProSummary page 5…e(s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission is shown as follow; Predicate Device #1 510(k) Number K191026 Trade/Device/Model Name MEDIP PRO Device Classification Name System, Image Processing, Radiologica… | 2019 |
| * | K130542 | Synapse 3D Lung and Abdomen AnalysisSummary page 5…LLZ Device Class II 510(k) Review Panel Radiology Predicate Device #2 510(k) Number K130542 Trade/Device/Model Name SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS Device Classification Name System, Im… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253944 | Data Analysis Facilitation Suite (DAFS) | 2026 | 0 |
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 2.4 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K253944 (Voronoi Health Analytics Incorporated, 2026) has gone furthest, with 0 descendants 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?
DeepCatch analyzes CT images and auto-segments anatomical structures (skin, bone, muscle, visceral fat, subcutaneous fat, internal organs and central nervous system). Then, its volume and proportions are calculated and provided with the relevant 3D model.
By using DeepCatch, it is possible to obtain accurate values for the volume and proportion of each anatomical structures by secondary utilization of CT images obtained for various purposes in the medical field. The type of input data is whole body CT. This device is intended to be used in conjunction with professional clinical judgement. The physician is responsible for inspecting and confirming all results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223556 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223556: DeepCatch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223556
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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