The ImagingRing m is a mobile x-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony anatomy and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required. The ImagingRing m provides an interface that can be used by system integrators for integration of the ImagingRing m with image guidance systems such as surgical navigation systems.

Device Description

The ImagingRing m (Version 2.0) is from a technical point of view the same system as its already approved predecessor ImagingRing m (K203281). The only difference is the implementation of a new x-ray source in combination with a software upgrade, which allows for higher power settings. The ImagingRing m functions as a mobile x-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony anatomy and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required. The ImagingRing m (Version 2.0) provides an interface that can be used by system integration of the ImagingRing m (Version 2.0) with image guidance systems such as surgical navigation systems.

The ImagingRing m (Version 2.0) consists of the ring gantry and respective arms carrying the X-Ray source and directly integrates all necessary electronic and components along with low-level software to realize coordinated motion and X-ray emission in the device's ring carrier and legs. The ImagingRing m (Version 2.0) device also provides a detachable Remote Control Panel (RCP) component that provides a display and controls elements such that users can interact with the machine.

AI/ML Overview

This document is a 510(k) Summary for the medPhoton GmbH ImagingRing m (Version 2.0), Loop-X (Version 2.0), and Loop-X Mobile Imaging Robot (Version 2.0). It focuses on demonstrating substantial equivalence to a predicate device, K203281 (ImagingRing m). The provided text describes the changes in the new version (primarily a new X-ray source allowing higher power settings and associated software upgrades) and the testing conducted to support its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study as per your request, based only on the provided text:

Important Note: The provided text is a 510(k) Summary, which is a high-level overview. It does not contain detailed acceptance criteria tables, specific statistical results from performance studies, or granular details about ground truth establishment and expert qualifications often found in a full study report or 510(k) submission. Therefore, some information requested might not be explicitly present and can only be inferred or stated as 'not provided'.

Acceptance Criteria and Study Details

The document states that the testing aimed to evaluate whether the new features (increased kVp, infrared motion compensation, extended Field of View) negatively impact diagnostic accuracy and usability, and to confirm that they provide benefits without altering total radiation dose or degrading image clarity.

Given the nature of a 510(k) submission and the information provided, the "acceptance criteria" are implied to be that the new device's performance, particularly in terms of image quality and diagnostic utility, is non-inferior or superior to the predicate device, especially considering the new features. Specific quantitative acceptance criteria (e.g., minimum SNR, maximum artifacts) are not explicitly listed in the summary.

Here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implied)	Reported Device Performance
Image Quality at Higher kVp (140 kVp vs. 120 kVp): Diagnostic accuracy and usability should not be negatively impacted.	"Cadaver studies compared 3DCBCT images acquired at 120 kVp, demonstrating that the increased tube voltage does not negatively impact image quality. Instead, higher penetration particularly for larger patients or cases involving metallic implants." This indicates non-inferiority in image quality and superiority in penetration for certain cases, meeting the implied criterion.
Effectiveness of Infrared-Based Motion Compensation: Reduction of motion-related artifacts; no alteration of total radiation dose.	"It was confirmed that this feature improves image quality without altering total radiation dose. This finding is particularly relevant in cases where respiratory motion or involuntary patient movement could otherwise degrade image clarity." This indicates improvement in image quality (artifact reduction) without increased dose, meeting the implied criterion.
Extended Field of View (FOV) Techniques (Longitudinally extended 3D imaging and 2D topogram scanning): Enhanced anatomical coverage, improved workflow efficiency, maintenance of high image quality, and adherence to radiation principles.	"It was demonstrated that extended FOV scanning enhances workflow efficiency while maintaining high image quality and adhering to radiation principles." This indicates enhanced workflow and maintained image quality/radiation principles, meeting the implied criterion.
Overall Clinical Performance / Substantial Equivalence: New features should not negatively impact overall clinical performance.	"Across all evaluated features, clinical and non-clinical evaluations introduced in the subject device do not negatively impact its clinical performance. Instead, enhancements such as higher X-ray energy, motion compensation, and extended FOV capabilities provide tangible benefits in patient imaging, these non-clinical imaging studies, through the comparison of image quality, artifacts, anatomical representation, and dose, demonstrate the substantial equivalence of the devices with the tested new features to their respective base versions or similar devices." This is the overarching conclusion of the substantial equivalence claim.

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set Sample Sizes: Not explicitly stated with specific numbers of cases or subjects. The text mentions "cadaver studies" and "clinical studies involved patient imaging."
Data Provenance:
- Country of Origin: "Cadaver studies (e.g. at Highridge Cadaver Lab in the US, Paracelsus Medical University (PMU) in Salzburg, Austria)." This indicates data from both the US and Austria. "Evaluations at reference customer sites" suggests other clinical sites, but specific locations are not given.
- Retrospective or Prospective: Not explicitly stated. "Clinical studies involved patient imaging under standard operating conditions to validate the new features' impact in routine diagnostic settings" suggests a prospective approach for the clinical portion, while cadaver studies are inherently prospective for the device testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. The text mentions "renowned institutions" and "reference customer sites" implying medical professionals (e.g., radiologists, surgeons) were involved, but their specific roles, experience, or certifications are not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The general phrasing "evaluations" and "comparison" does not specify a formal adjudication process.

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

Was it done? Not explicitly stated as a formal MRMC study. While "comparison of image quality, artifacts, anatomical representation, and dose" was performed, the summary doesn't detail if multiple human readers quantitatively evaluated cases with and without AI assistance (the AI here refers to the software-driven features like motion compensation rather than a traditional AI algorithm for diagnosis). The study design seems to focus on the technical performance and the clinical utility of the device features rather than a direct comparison of human reader performance with and without AI assistance for interpretation.
Effect Size: Not provided.

6. Standalone Performance (Algorithm only without human-in-the-loop performance)

The term "standalone" typically applies to AI algorithms making automated diagnoses. Here, the "AI" or advanced features (motion compensation, extended FOV) are integrated into an imaging device. The "performance" described is largely the technical performance of the imaging system with these features. For example, motion compensation improves image quality, which then benefits human interpretation. The text focuses on the device's performance characteristics with these new features, not an AI algorithm's diagnostic output.

7. Type of Ground Truth Used

For Image Quality/Feature Assessment:
- Cadaver Studies: Used to assess impact of higher kVp on image quality, and effectiveness of motion compensation in reducing artifacts. The "ground truth" here is the physical reality within the cadavers and the absence/presence of motion artifacts under controlled conditions. Comparison was made against images acquired at different settings or without compensation.
- Clinical Studies: Used to "validate the new features' impact in routine diagnostic settings" and assess "workflow efficiency." The ground truth for image quality would be subjective clinical assessment by clinicians and objective measurement of image characteristics. For workflow, it would be observed efficiency.
No explicit "diagnostic ground truth" (e.g., pathology confirmed disease state) is mentioned, as the study focuses on the image acquisition system's performance, not a specific diagnostic task like lesion detection.

8. Sample Size for the Training Set

Sample Size: Not provided. As this is a 510(k) for an imaging device (updated hardware and software features), not a deep learning AI diagnostic algorithm, the concept of a "training set" in the context of machine learning model development might not directly apply in the same way. The software upgrades are likely to control the hardware parameters and image reconstruction based on engineering principles and pre-defined algorithms, not necessarily a data-driven "training" in the AI/ML sense. If any internal models were trained (e.g., for motion detection), details are not provided.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" in the context of an AI/ML model for diagnosis is not mentioned as part of the submission, how its "ground truth" was established is also not applicable or not provided. The development and verification of the system's features would rely on engineering specifications, phantom studies, and possibly empirical adjustments based on cadaver/clinical imaging, rather than annotated training data for a diagnostic algorithm.

Summary

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March 28, 2025

medPhoton GmbH % Thomas Fessmann Quality Management and Regulatory Affairs Karolingerstraße. 16 Salzburg, Salzburg 5020 AUSTRIA

Re: K234067

Trade/Device Name: ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB Dated: February 26, 2025 Received: February 26, 2025

Dear Thomas Fessmann:

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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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 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-reportingcombination-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

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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Indications for Use

Submission Number (if known)

K234067

Device Name

ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)

Indications for Use (Describe)

The ImagingRing m is a mobile x-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony anatomy and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required. The ImagingRing m provides an interface that can be used by system integrators for integration of the ImagingRing m with image quidance systems such as surgical navigation systems.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

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510(k) #: K234067

510(k) Summary

Prepared on: 2025-03-28

Contact Details

21 CFR 807.92(a)(1)

Applicant Name	medPhoton GmbH
Applicant Address	Karolingerstraße 16 Salzburg Salzburg 5020 Austria
Applicant Contact Telephone	+436603771967
Applicant Contact	Mr. Thomas Fessmann
Applicant Contact Email	thomas.fessmann@medphoton.at
Correspondent Name	medPhoton GmbH
Correspondent Address	Karolingerstraße 16 Salzburg Salzburg 5020 Austria
Correspondent Contact Telephone	+4369916105406
Correspondent Contact	Dr. Daniel Schaffarzick
Correspondent Contact Email	daniel.schaffarzick@medphoton.at
Device Name	21 CFR 807.92(a)(2)
Device Trade Name	ImagingRing m (Version 2.0);Loop-X (Version 2.0);Loop-X Mobile Imaging Robot (Version 2.0)
Common Name	Interventional Fluoroscopic X-Ray System
Classification Name	Image-intensified Fluoroscopic X-Ray System
Regulation Number	892.1650
Product Code	OWB
Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K203281	ImagingRing m	OWB

The ImagingRing m (Version 2.0) consists of the ring gantry and respective arms carrying the X-Ray source and directly

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integrates all necessary electronic and components along with low-level software to realize coordinated motion and X-ray emission in the device's ring carrier and legs. The ImagingRing m (Version 2.0) device also provides a detachable Remote Control Panel (RCP) component that provides a display and controls elements such that users can interact with the machine.

Intended Use/Indications for Use

Indications for Use Comparison

The indications for use are the same.

Technological Comparison

The device has the same technological characteristics as its predecessor device. The difference is used in combination with a software upgrade to achieve higher power settings. The predecessor's available energy is 40-120 kV and the new device's (Version 2.0) available energy is 40-140 kV with the new x-ray source and software upgrade new features were introduced to the 2.0 device, such as the infrared quided motion compensation and 3D extended field of view (Multislit / Multi-slice) imaging.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Summary of Non-Clinical and Clinical Testing Supporting Substantial Equivalence

As part of the comprehensive non-clinical testing conducted to evaluate the subject device and its new features, multiple studies have been carried out in collaboration with renowned institutions. These investigations encompass a variety of testing environments, including cadaver studies (e.g. at Highridge Cadaver Lab in the US, Paracelsus Medical evaluations at reference customer sites, to ensure a thorough assessment of the device's performance, safety, and usability.

Overview of Testing Approach

The testing framework incorporated both non-clinical methodologies to provide a robust foundation for determining substantial equivalence. Non-clinical testing includes performed at multiple institutions, aiming to simulate real-world conditions while maintaining control variables. Clinical studies involved patient imaging under standard operating conditions to validate the new features' impact in routine diagnostic settings.

Key Investigations and Findings

One of the primary objectives was to analyze whether X-ray energy option (140 kVp) affects diagnostic accuracy and usability. Cadaver studies compared 3DCBCT images acquired at 120 kVp, demonstrating that the increased tube voltage does not negatively impact image quality. Instead, higher penetration particularly for larger patients or cases involving metallic implants.

The implementation of infrared-based motion was assessed through both cadaver and clinical studies, evaluating its effectiveness in reducing motion-related artifacts. By acquiring and reconstructing images with and without motion compensation, it was confirmed that this feature improves mage quality without altering total radiation dose. This finding is particularly relevant in cases where respiratory motion or involuntary patient movement could otherwise degrade image clarity.

The introduction of extended Field of View (FOV) techniques, including longitudinally extended 3D imaging and 2D topogram scanning, was also rigorously evaluated. These features alow for better anatomical coverage, facilitating more precise planning of subsequent CBCT scans. Through a combination of clinical and cadaver studies, it was demonstrated that extended FOV scanning enhances workflow efficiency while maintaining high image quality and adhering to radiation principles.

The following FDA Guidances have been used:

Content of Premarket Submissions for Device Software For Industry and Food and Drug Administration Staff June 2023 - used for the preparation of this 5 10k submission.
Cybersecurity in Medical Devices: Quality System Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff September 2023.
Pediatic Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff November 2017.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

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Standards Used in the development and testing: IEC 62304:2015 IEC 60601-1:2005 + A1:2012 IEC 60601-1-2:2014 IEC 60601-1-3:2008 + A1:2013 IEC 60601-1-6:2010 + A1:2013 IEC 60601-2-28:2017 IEC 60601-2-43:2010/AMD1:2017 IEC 60601-2-54:2009/AMD2:2018

Conclusion:

Across all evaluated features, clinical and non-clinications introduced in the subject device do not neqatively impact its clinical performance. Instead, enhancements such as higher X-ray energy, motion compensation, and extended FOV capabilities provide tangible benefits in patient imaging, these non-clinical imaging studies, through the comparison of image quality, artifacts, anatomical representation, and dose, demonstrate the substantial equivalence of the devices with the tested new features to their respective base versions or similar devices.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.