The RiaspDR software directly controls and acquires general radiographic images of human anatomy (excluding fluoroscopic, angiographic, dental and mammographic applications). The RiaspDR software is designed to work with X-ray images from the Mars1417X detector (K210316).

Device Description

RIASPDR is Radiographic Imaging Acquisition Software Platform. RIASPDR software directly controls and acquires images from Mars1417X detector(K210316) whose manufacturer is iRay Technology. Furthermore, RIASPDR acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system.

AI/ML Overview

The provided FDA 510(k) clearance letter and supporting documentation for the Shen Zhen Cambridge-hit Digital Radiographic Imaging Acquisition Software - DR (RiasDR) do not contain detailed information about the specific acceptance criteria and the comprehensive study that proves the device meets these criteria.

The document states:

"Software verification and validation testing were conducted and documentation was provided in this 510(k). Results demonstrated that the predetermined acceptance criteria were met."
"Software Verification and Validation Testing was performed in accordance with internal requirements, international standards and guidance shown below, the safety and effectiveness of RIASPDR were supported, and the substantial equivalence to the predicate device was demonstrated."
"Clinical testing: Not applicable."

This indicates that acceptance criteria were defined and met through non-clinical testing, but the specifics of these criteria and the methodology of the study are not included in this extract. The document mainly focuses on comparative equivalence to a predicate device (Econsole1, K152172) and adherence to general software validation guidelines and DICOM standards.

Therefore, I cannot provide a detailed answer to your request based solely on the provided text, as the specific information about the acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC study, standalone performance, and ground truth establishment is not present.

However, I can extract the available information and highlight what is missing based on your request:

Device: Digital Radiographic Imaging Acquisition Software - DR (RiasDR)

Study Type: Non-clinical (Software Verification and Validation Testing)

1. Acceptance Criteria and Reported Device Performance

The document specifies performance deviations for certain measurement functions, which likely serve as a subset of the acceptance criteria. However, a complete table of acceptance criteria and a detailed breakdown of all reported device performance metrics are not provided.

Partial Acceptance Criteria (from "5. Device specification"):

Acceptance Criteria	Reported Device Performance
Deviation of length measurement: <= 5%	The document states these criteria "should not exceed" the specified values, implying the device met them. No specific measured values are reported.
Deviation of area measurement: <= 10%
Deviation of perimeter measurement: <= 5%
Deviation of angle indication value from actual value: within ±0.5°

Missing Information: A comprehensive table of all acceptance criteria the device was tested against and the corresponding quantitative results showing the device met these criteria.

2. Sample Size and Data Provenance

Test Set Sample Size: Not specified.
Data Provenance: The document states "Software verification and validation testing were conducted." It does not specify the origin of the data used for this testing (e.g., country of origin, retrospective or prospective). Given it's non-clinical software testing, it likely involves simulated data, synthetic data, and/or a collection of de-identified real-world medical images, but this is not specified.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
- Since clinical testing was noted as "Not applicable," expert review for clinical ground truth is unlikely to be a primary method for this specific 510(k) submission, unless experts were involved in verifying the non-clinical test data or the accuracy of image processing algorithms against known standards. This is not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the non-clinical nature of the testing described (software verification and validation), traditional expert adjudication methods (e.g., 2+1, 3+1) are unlikely to be detailed here unless specifically applied to the generation of a 'ground truth' for image quality metrics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, implicitly. The document explicitly states "Clinical testing: Not applicable." An MRMC study would fall under clinical testing.

6. Standalone Performance (Algorithm Only)

Was standalone performance done? The software verification and validation testing likely assessed the algorithm's performance in a standalone context against defined functional and performance requirements. However, specific metrics (e.g., sensitivity, specificity, AUC for a diagnostic task) for algorithm-only performance are not provided in this document. The focus of the "Device specification" section is on measurement accuracy rather than a diagnostic performance.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the non-clinical testing would relate to the accuracy of image acquisition, processing, and measurement functions. This would likely involve:
- Known input parameters/standards: For verifying that the software correctly controls the X-ray detector and acquires images.
- Defined geometric shapes/patterns: For verifying the accuracy of length, area, perimeter, and angle measurements.
- DICOM compliance: Ground truth related to adherence to DICOM standards for image transmission and storage.
- The document does not mention ground truth based on expert consensus, pathology, or outcomes data, as clinical testing was not applicable.

8. Training Set Sample Size

Training Set Sample Size: Not applicable/Not specified. The RiasDR is described as "Digital Radiographic Imaging Acquisition Software - DR." This type of software typically manages image acquisition and processing rather than employing machine learning algorithms that require a "training set" in the conventional sense (i.e., for diagnostic prediction models). Its function is to control the detector and process images (e.g., viewing, search, storage, annotation, measurement, processing). There's no indication it's an AI/ML diagnostic aid requiring a training set.

9. How Ground Truth for Training Set was Established

Not applicable/Not specified, as there is no indication of a training set for an AI/ML model for diagnostic purposes.

Summary

FDA 510(k) Clearance Letter - Digital Radiographic Imaging Acquisition Software

Page 1

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

Doc ID # 04017.08.00

August 6, 2025

Shen Zhen Cambridge-hit Co., Ltd.
℅ Fu Field
Senior Consultant
Shenzhen Joyantech Consulting Co., Ltd.
1713A, Block A, Zhongguan Times Square, Liuxian Avenue
Xili Town, Nanshan District
Shenzhen, GD 518000
China

Re: K251038
Trade/Device Name: Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: July 7, 2025
Received: July 7, 2025

Dear Fu Field:

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.

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K251038 - Fu Field
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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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 systems (QS) regulation (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

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K251038 - Fu Field
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Lamb
Assistant Director
Imaging Software Team
DHT8B: Division of Radiologic Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K251038

Device Name
Digital Radiographic Imaging Acquisition Software - DR (RiasDR)

Indications for Use (Describe)
The RiaspDR software directly controls and acquires general radiographic images of human anatomy (excluding fluoroscopic, angiographic, dental and mammographic applications). The RiaspDR software is designed to work with X-ray images from the Mars1417X detector (K210316).

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
PRAStaff@fda.hhs.gov

"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."

Page 5

Shen Zhen Cambridge-hit [510(k)] Application

K251038

510(k) Summary

1. Contact Details

1.1 Applicant information

Applicant Name	Shen Zhen Cambridge-hit Co., Ltd.
Address	1st Floor, Building A1, Hualianfeng Building, Huaning Road, Dalang Street, Longhua District, Guangdong Province, China.
Phone No.	+86(755)23226094
Contact person	Ming Zhao
Date Prepared	Apr. 7, 2025
E-mail	ming.zhao@iraygroup.com

1.2 Proposed device manufacturer

Applicant Name	iRay Group
Address	No. 999, Huanqiao Road, Pudong New Area 201315, Shanghai, China.

1.3 Submission Correspondent

Shenzhen Joyantech Consulting Co., Ltd
1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong, 518000, China

Phone No.	+86-755-86069197
Contact person	Field Fu
Contact person's e-mail	field@cefda.com
Website	http://www.cefda.com

2. Device information

Trade name	Digital Radiographic Imaging Acquisition Software Platform – DR (RIASPDR)
Model	Not applicable
Classification	Ⅱ
Classification name	Radiology
Product code	LLZ
Regulation No.	892.2050

3. Legally Marketed Predicate Device

Trade Name	Econsole1
510(k) Number	K152172

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Shen Zhen Cambridge-hit [510(k)] Application

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Product Code	LLZ
Manufacturer	DRTECH Corporation

4. Device Description

5. Device specification

The deviation of the length measurement should not exceed 5%; The deviation of the area measurement should not exceed 10%; The deviation of the perimeter measurement should not exceed 5%; The deviation of the angle indication value from the actual value should be within ±0.5°.

6. Intended Use/Indication for Use

7. Substantial Equivalence Comparison

Item	Subject Device	Predicate Device: (K152172)	Comments
Regulation number	892.2050	892.2050	Same
Classification	Ⅱ	Ⅱ	Same
Product Code	LLZ	LLZ	Same
Intended use/Indications for use	The RiaspDR software directly controls and acquires general radiographic images of human anatomy (excluding fluoroscopic, angiographic, dental and mammographic applications). The RiaspDR software is designed to work with X-ray images from the Mars1417X detector	The Econsole1 software is indicated for use in general radiographic images of human anatomy (excluding fluoroscopic, angiographic, and mammographic applications).	Same

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Shen Zhen Cambridge-hit [510(k)] Application

Item	Subject Device	Predicate Device: (K152172)	Comments
(K210316).
Acquisition devices	Digital X-ray Detector	Digital X-ray Detector	Same
Software Function	Image viewing; Image search; Image storage; Image annotation; Image measurement; Image processing;	Image viewing; Image search; Image storage; Image annotation; Image measurement; Image processing; Image stitch	Same
DICOM 3.0 Compatibility	Yes	Yes	Same
Wireless function	Yes, by TCP/IP or WIFI. The software interacts with the Flat Panel Detector (FPD, that is, Digital X-ray Detector) by calling the driver provided by the manufacturer of the FPD. The data interaction between the FPD and the software can be wired or wireless, depending on the Design of the FPD.	No	Different (note)

8. Non-clinical Testing

As required by FDA Guidance, Software verification and validation testing were conducted and documentation was provided in this 510(k). Results demonstrated that the predetermined acceptance criteria were met.

Software Verification and Validation Testing was performed in accordance with internal requirements, international standards and guidance shown below, the safety and effectiveness of RIASPDR were supported, and the substantial equivalence to the predicate device was demonstrated:

--- Content of Premarket Submissions for Device Software Functions, issued on June 14, 2023.

---Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, issued on September 27, 2023.

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Shen Zhen Cambridge-hit [510(k)] Application

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---Digital Imaging and Communications in Medicine (DICOM) Set.

9. Clinical testing

Not applicable.

10. Conclusions Drawn from Non-Clinical and Clinical Tests

Based on device comparison information and non-clinical bench testing, the subject device is substantially equivalent to legally marketed predicate devices (K152172).

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).