510(k) · Cleared
ClearedInferOperate Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Infervision Healthcare Medical Technology Co., Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Sep 15, 2025 as substantially equivalent to K212896 (Visible Patient, Sas, 2021) after a 231-day review. Its family tree reaches back 15 generations to 1991. 1 later device descends from it.
- Decided
- Sep 15, 2025
- Review
- 231 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K913770 (1991). 137 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations between
- 3 generations backK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
- 2 generations backK151988 Visible Patient SuiteVisible Patient, Sas · 2015
- 1 generation backK212896 Visible Patient SuiteVisible Patient, Sas · 2021
- This deviceK250237 InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK260973 InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2026
Show all 15 generations
- Root · 15 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 14 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 13 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 12 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 11 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 10 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 9 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 8 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 7 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 6 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 5 generations backK072821 Vitrea 4DCTVital Images, Inc. · 2008 · Recalled
- 4 generations backK121213 VitreaadvancedVital Images, Inc. · 2012 · Recalled
- 3 generations backK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
- 2 generations backK151988 Visible Patient SuiteVisible Patient, Sas · 2015
- 1 generation backK212896 Visible Patient SuiteVisible Patient, Sas · 2021
- This deviceK250237 InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −14 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −13 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −12 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −11 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −10 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −9 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −8 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −7 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −6 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −5 | K072821 | Vitrea 4DCT | Vital Images, Inc. | 2008 | 1 |
| −4 | K121213 | Vitreaadvanced | Vital Images, Inc. | 2012 | 1 |
| −3 | K142521 | Synapse 3D Liver and Kidney Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
| −2 | K151988 | Visible Patient Suite | Visible Patient, Sas | 2015 | — |
| −1 | K212896 | Visible Patient Suite | Visible Patient, Sas | 2021 | — |
| 0 (this device) | K250237 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2025 | — |
| +1 | K260973 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 9 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 15 | 0 |
| 2002 | 9 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 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 23.5 · 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 |
|---|---|---|---|
| * | K212896 | Visible Patient SuiteSummary page 5…uite Manufacturer: Visible Patient, SAS Common Name: system, image processing, radiological Classification: Class II 510(k) Number: K212896 Regulation Number: 21 CFR 892.2050 Classification Panel: Radiology Product Code: LLZ… | 2021 |
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 |
|---|---|---|---|
| K260973 | InferOperate Suite | 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 34 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 32 of the 137 ancestors have a recall of any class.
- Of its descendants, K260973 (Beijing Infervision Healthcare Medical Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K212896.
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. 2025, 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?
InferOperate Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for patients, including both preoperative surgical planning and intraoperative image display. InferOperate Suite accepts DICOM compliant medical images acquired from a variety of imaging devices. This product is not intended for use with or for the primary diagnostic…
Read the full statement (224 words)
InferOperate Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for patients, including both preoperative surgical planning and intraoperative image display. InferOperate Suite accepts DICOM compliant medical images acquired from a variety of imaging devices.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
It provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), surface rendering, measurements, surgical planning, reporting, storing, general image management and administration tools, etc.
It includes a basic image processing workflow and a custom UI to segment anatomical structures. The processing may include the generation of preliminary segmentations of anatomy using software that employs machine learning and other computer vision algorithms, as well as interactive segmentation tools, etc.
InferOperate Suite is designed for use by trained professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
InferOperate Suite utilizes machine learning-based algorithms for adult patients undergoing CT chest, abdominal, or pelvic scans. For image data of other anatomical regions or modalities, patients under 21 years of age, or patients with unknown age, we provide non-ML software functions, such as STL viewer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250237: InferOperate Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250237
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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