InferCare RECIST

K252261 · Beijing Infervision Healthcare Medical Technology Co., Ltd. · QIH · Mar 13, 2026 · Radiology

Device Facts

• Record ID: K252261
• Device Name: InferCare RECIST
• Applicant: Beijing Infervision Healthcare Medical Technology Co., Ltd.
• Product Code: QIH · Radiology
• Decision Date: Mar 13, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

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.

Device Story

Post-processing software for multi-time-point CT images; used by radiologists and oncologists in hospitals/clinics. Ingests DICOM CT images; performs automated lesion segmentation and registration using AI algorithms; provides interactive tools for 3D reconstruction, MPR, and MIP. Physician selects lesions; software tracks and compares across follow-up studies; generates RECIST-standard reports. Output assists clinicians in tumor management, lesion measurement, and diagnostic/treatment decision-making. Results require professional confirmation.

Clinical Evidence

Bench testing only. Performance evaluated on 212 target objects for registration (Match Rate 0.995; Centroid Error MAE 2.44mm). Segmentation accuracy tested on 102 cases (lung, liver, kidney, lymph node); mean Dice scores ranged from 0.782 to 0.929; Long/Short diameter MAE ranged from 3.2% to 5.3%.

Technological Characteristics

Software-based medical image processing system. Utilizes AI algorithms for automated segmentation and registration. Supports DICOM standard. Features include 2D viewing, 3D reconstruction, MPR, MIP, and interactive segmentation editing. Deployed in healthcare facilities or cloud-based platforms. Compliant with IEC 62304 and ISO 14971.

Indications for Use

Indicated for trained medical professionals to evaluate and manage tumors in various organs, tissues, and anatomical structures using RECIST criteria on multi-time-point CT images. AI algorithms are indicated for patients aged 21 years and older.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Multi-Modality Tumor Tracking (MMTT) application (K162955)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 13, 2026

Beijing Infervision Healthcare Medical Technology Co., Ltd.
% Matt Deng
Primary Contact
Room B403, 4th Floor, Building 1
No.12, Shangdi Information Road, Haidian District
BEIJING, 100085
CHINA

Re: K252261
Trade/Device Name: InferCare RECIST
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: QIH
Dated: February 12, 2026
Received: February 12, 2026

Dear Matt Deng:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,


Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252261 | |
| Device Name InferCare RECIST | |
| Indications for Use (Describe) 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. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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InferCare RECIST

# 510(k) Summary-K252261

## InferCare RECIST

**Submitter:** Beijing Infervision Healthcare Medical Technology Co., Ltd.

**Address:** Room B403, 4th Floor, Building 1, No.12, Shangdi Information Road, Haidian District, Beijing 100085, China. Phone: [phone]

**Contact:** Mr. Matt Deng
Email: [e-mail]
Phone: [phone]

**Date Prepared:** March 12, 2026

## Device Name and Classification

- **Trade Name:** InferCare RECIST
- **Classification:** Class II
- **Common Name:** Automated radiological image processing software
- **Regulation Name:** Medical image management and processing system
- **Regulation Number:** 21 CFR 892.2050
- **Classification Panel:** Radiology
- **Product Code:** QIH

## Predicate Device

- **Trade Name:** Multi-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 system
- **Regulation Number:** 21 CFR 892.2050
- **Classification Panel:** Radiology
- **Product Code:** LLZ

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InferCare RECIST

# Device Description

InferCare RECIST is based on advanced image processing technologies and temporal sequence analysis methods. The software can be installed in a healthcare facility or a cloud-based platform. It ingests medical imaging data compliant with the DICOM standard and supports multi-timepoint image registration. It allows automatic navigation to match lesion locations across different image series based on physician-selected lesions, ensuring accurate tracking and comparison of the same lesion across follow-up studies.

InferCare RECIST integrates machine learning based algorithms to provide interactive segmentation tools, enabling users to generate 3D segmentation and measurement results simply by clicking on the target lesion.

In addition, the system offers a variety of image processing tools, such as window width/level adjustment, multi-planar reconstruction (MPR), and maximum intensity projection (MIP), to meet the needs of different clinical viewing scenarios. Through the integrated use of these technologies, InferCare RECIST delivers accurate lesion measurements, follow-up trend analyses, and RECIST-standard evaluation reports, effectively supporting physicians in making precise diagnostic and treatment decisions.

# Indications for Use

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.

# Substantial Equivalence

The subject device is substantially equivalent to the predicate device in the following ways:

| Item | Subject Device: InferCare RECIST | Predicate Device: Multi-Modality Tumor Tracking (MMTT) application | Comparison |
| --- | --- | --- | --- |
| Application Number | K252261 | K162955 | - |
| Product Code | QIH | LLZ | - |
| Class | Class II | Class II | Same |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |

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| Item | Subject Device: InferCare RECIST | Predicate Device: Multi-Modality Tumor Tracking (MMTT) application | Comparison |
| --- | --- | --- | --- |
| Indications for Use/ Intended use | 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. | Multi-Modality Tumor Tracking (MMTT) application is a post processing software application used to display, process, analyze, quantify and manipulate anatomical and functional images, for CT, MR PET/CT and SPECT/CT images and/or multiple time-points. The MMTT application is intended for use on tumors which are known/confirmed to be pathologically diagnosed cancer. The results obtained may be used as a tool by clinicians in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. | Same. Both devices are used for medical image processing to display, process, analyze, quantify, manipulate multi-time-point images and enable RECIST 1.1 categorization. |
| Intended Users | Radiologists, oncologists, and others trained in reading medical images and applying RECIST criteria | Radiologists, Technologist | Same |
| Where used | Healthcare facilities such as hospitals and clinics | Healthcare facilities such as hospitals and clinics | Same |
| Image Input | CT DICOM images | CT, MR, PET/CT and SPECT/CT DICOM images | Similar. The predicate device includes a wider variety |

InferCare RECIST

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| Item | Subject Device: InferCare RECIST | Predicate Device: Multi-Modality Tumor Tracking (MMTT) application | Comparison |
| --- | --- | --- | --- |
| | | | of imaging modalities. |
| 2D DICOM viewing | Yes | Yes | Same |
| 3D Reconstruction | Automatic | Automatic | Same |
| Multi-Planar Reconstructions (MPR) | Yes | Yes | Same |
| Registration | Automatic and manual | Automatic and manual | Same |
| Lesion segmentation | Semi-automatic and manual | Semi-automatic and manual | Same |
| Segmentation editing tools | Add, Delete, Edit, Undo | Add, Delete, Edit, Undo | Same |
| Automatic software measurement of segmented lesion | Long axis, short axis, volume, key slice. | Long axis, short axis, volume, key slice, density, etc. | Same |
| RECIST Report | Yes | Yes | Same |
| Algorithm characteristics | Artificial Intelligence (AI) algorithm | Traditional algorithm | The algorithm performance of the subject device has been validated through performance testing. |

The subject device and the predicate device are substantially equivalent in indications for use, input/output, image registration, and interactive lesion segmentation. Regarding the technical differences between the two devices, standalone performance testing has demonstrated that the subject device meets the predetermined target values.

## Performance data

Software verification and validation activities were conducted in accordance with IEC 62304:2006+A1:2015 – Medical device software – Software lifecycle processes and ISO 14971:2019 Medical devices – Application of risk management to medical devices, and in accordance with relevant FDA guidance documents, Guidance for the Content of Premarket Submissions for Device Software Functions (issued June 14, 2023), and Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued September 27, 2023).

InferCare RECIST

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Cybersecurity and vulnerability analyses were conducted, and it has been determined that InferCare RECIST conforms to the cybersecurity requirements.

The following processes were followed and applied during the design and development of InferCare RECIST:

- Risk Analysis
- Unit Testing
- Integration Testing
- System Testing
Performance Testing
- Software Verification & Validation
- Cybersecurity Testing and Analysis

# Performance of AI algorithm

# 1. Image Registration Performance Test

(1) For the primary endpoint: Match Rate, a total of 212 target objects including 184 paired, 21 new and 7 disappeared target objects were annotated as ground truth. Among all 212 pairs, 183 paired, 21 new and 7 disappeared target objects were successfully matched across prior and primary scans by InferCare RECIST. Patient-level bootstrapping: the Match Rate was 0.995 (95% CI: 0.986-1.000), with the lower limit of the 95% C.I. being 0.986.
(2) For the secondary endpoint: Centroid Error Distance: Patient-level bootstrapping: A total of 183 successfully matched target object pairs in 86 patient-scans were included in the analysis. The MAE of centroid error distance was $2.44\mathrm{mm}$ (95% C.I.: $2.22\mathrm{mm} - 2.68\mathrm{mm}$ ), with the higher limit of the $95\%$ C.I. being $2.68\mathrm{mm}$ .

# 2. Lesion Segmentation Performance Test

(1) Segmentation accuracy was set as the primary endpoint, and Long/Short diameter measurement was set as the secondary endpoint. We used the same batch of data to test these two endpoints. The dataset comprises a total of 102 cases, including 42 cases of lung nodules, 23 cases of liver lesions, 23 cases of kidney lesions, and 14 cases of lymph node lesions. The result is listed below:

| | | Primary endpoint Segmentation Accuracy | | Secondary endpoint Long/Short Diameter | |
| --- | --- | --- | --- | --- | --- |
| Item | N | Mean (Dice) | 95% CI | MAE (%) | 95% CI |
| Lung nodule | 42 | 0.913 | 0.895-0.932 | 3.2 | 2.2-4.2 |
| Liver lesion | 23 | 0.929 | 0.913-0.944 | 4.3 | 3.1-5.5 |
| Kidney lesion | 23 | 0.904 | 0.889-0.918 | 4.5 | 3.3-5.6 |
| Lymph node | 14 | 0.782 | 0.750-0.814 | 5.3 | 3.0-7.6 |

InferCare RECIST

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# Conclusion

The InferCare RECIST is substantially equivalent in intended use, main functions, operating principles, and safety features to the predicate device. The minor differences in technological characteristics do not raise different questions of safety or effectiveness. The performance testing reports and the submitted documentations demonstrate that the subject device and the predicate device are substantially equivalent.

InferCare RECIST