510(k) · Cleared
ClearedInferCare RECIST
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 Mar 13, 2026 as substantially equivalent to K162955 (Philips Medical Systems Nederland B.V., 2016) after a 235-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Mar 13, 2026
- Review
- 235 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K913770 (1991). 103 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 1 generation backK162955 Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. · 2016
- This deviceK252261 InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2026
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 9 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 8 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 7 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 6 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 4 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 1 generation backK162955 Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. · 2016
- This deviceK252261 InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −9 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −8 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −7 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −6 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −4 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −2 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| −1 | K162955 | Multi-Modality Tumor Tracking (MMTT) application | Philips Medical Systems Nederland B.V. | 2016 | — |
| 0 (this device) | K252261 | InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 10 | 0 |
| 2002 | 10 | 0 |
| 2003 | 3 | 0 |
| 2004 | 11 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K162955 | Multi-Modality Tumor Tracking (MMTT) applicationSummary page 5…lti-Modality Tumor Tracking (MMTT) application Manufacturer: Philips Medical Systems Nederland B.V. Classification: Class II 510(k) Number: K162955 Common Name: System, image processing, radiological Regulation Name: Medical image management and processing… | 2016 |
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 35 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 24 of the 103 ancestors have a recall of any class.
- 1 other device also cites its predicate K162955.
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?
InferCare RECIST is a post-processing software application used to display, process, analyze, quantify and manipulate multi-time-point CT images. It is intended to be used by trained medical professionals in evaluating and managing tumors in various organs, tissues, and other anatomical structures based on RECIST criteria. InferCare RECIST offers functionalities for lesion measurement, registration, tracking, and RECIST report. It provides tools for…
Read the full statement (102 words)
InferCare RECIST is a post-processing software application used to display, process, analyze, quantify and manipulate multi-time-point CT images. It is intended to be used by trained medical professionals in evaluating and managing tumors in various organs, tissues, and other anatomical structures based on RECIST criteria.
InferCare RECIST offers functionalities for lesion measurement, registration, tracking, and RECIST report. It provides tools for interactive segmentation, and 3D reconstruction visualization.
The software utilizes artificial intelligence algorithms for automated lesion segmentation and registration, and the results require confirmation by a medical professional. The software's artificial intelligence algorithms are intended for patients aged 21 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252261 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252261: InferCare RECIST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252261
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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