The Q-Rad Radiographic System is indicated for use in obtaining diagnostic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The Q-Rad System is not indicated for use in mammography

Device Description

The Q-Rad System is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wall-mounted image receptors/detectors for upright imaging, tube supports (ceiling-suspended or floormounted), x-ray tube, and collimator (beam-limiting device).

The Q-Rad System can be used with conventional analog (film cassette), digital radiography (DR) and computed radiography (CR) receptors. Systems equipped with DR or CR receptors can also be configured to include a workstation computer that is fully integrated with the x-ray generator.

The modified (subject) device is the previously cleared Q-Rad System stationary x-ray system which has been modified as follows:

Integration of the FDA-Cleared ImageView Software (K163203) with the Q-Rad ● System.
A circuit board (CIB+ Board) has been implemented on the Q-Rad System to ● facilitate a new communication protocol between the ImageView Software and the generator.
The QMI (Quantum Medical Imaging) high voltage generator has been replaced with a Carestream-designed high voltage generator.
The VacuTec Dose Area Product (DAP) meter Model 1560015 has been replaced ● with an equivalent DAP from a different supplier, the IBA Kermax plus with Ethernet interface 120-131 ETH (Standard Size).
The Generator Control Box has been replaced. This control box is used to switch ● the generator on and off. Changes to the control box are cosmetic only and do not impact its functionality.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information provided, focusing on the Q-Rad System:

This document is a 510(k) summary for a modified X-ray system, comparing it to a predicate device. It primarily focuses on demonstrating substantial equivalence rather than a clinical study proving new diagnostic performance. Therefore, many typical AI/software study elements (like expert ground truth, MRMC studies, specific performance metrics like AUC) are not detailed here because they aren't generally required for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied/Stated)	Reported Device Performance
Safety	No new unmitigated risks identified due to modifications.	Risk assessment of the modifications did not identify any new unmitigated risks.
Effectiveness/Performance	Conforms to specifications and provides equivalent safety and performance to predicate.	Non-clinical test results demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met, demonstrating the device is as safe, as effective, and performs as well as or better than the predicate device. Performance characteristics, operation/usability, intended workflow, related performance, overall function, verification, and validation of requirements were evaluated.
Software Requirements	Reliability of system software requirements.	Reliability of the system software requirements was demonstrated.
Regulatory Compliance	Meets recognized prevailing consensus standards.	Testing to recognized prevailing consensus standards was performed.
Functional Equivalence	Identical Indications for Use to the predicate device.	The Indications for Use for the subject device are identical to the predicate device's, and the intended use remains unchanged.
Hardware Equivalence	Components are equivalent or replacement does not impact functionality.	A circuit board, generator, and DAP meter were replaced with functionally equivalent or "cosmetically only" changed components. The ImageView Software (already cleared) was integrated.

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

This document describes non-clinical (bench) testing rather than a clinical study with patient data. Therefore, there is no "test set" in the traditional sense of patient cases or images for evaluating diagnostic performance. The testing was focused on the system's technical and functional performance.

Sample Size: Not applicable in the context of patient data. The "sample" would be the modified Q-Rad System itself and its components undergoing various bench tests.
Data Provenance: Not applicable for patient data. The testing was described as "non-clinical (bench) testing." No information on country of origin for any data or retrospective/prospective nature is provided, as it's not a clinical data study.

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

This information is not provided and is not applicable because the study described is non-clinical bench testing for substantial equivalence of an X-ray system, not a clinical diagnostic performance study requiring expert ground truth for patient findings.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that an MRMC study was performed. This submission is for an X-ray imaging system, not an AI-powered diagnostic algorithm for which an MRMC study would typically be conducted to evaluate human reader performance with and without AI assistance. The "ImageView Software" mentioned is already FDA-cleared (K163203) and its integration into the Q-Rad System is one of the modifications, but its diagnostic performance with human readers is not reassessed here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

This is not applicable. The Q-Rad System is an X-ray imaging device, not an AI algorithm performing a standalone diagnostic task. While it integrates an "ImageView Software," the 510(k) submission describes physical and software modifications to the system overall, not a standalone evaluation of an AI algorithm.

7. The Type of Ground Truth Used

This is not applicable for a clinical sense of "ground truth" (e.g., pathology, outcomes data). The ground truth for bench testing would typically involve engineering specifications, defined performance metrics, and compliance with consensus standards.

8. The Sample Size for the Training Set

This is not applicable. This document describes modifications to an existing X-ray system and its non-clinical testing. It does not mention any machine learning or AI models being trained as part of this specific submission. The ImageView Software is already cleared.

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

This is not applicable for the same reasons as #8.

Summary

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January 22, 2020

Carestream Health, Inc. Carolyn Wagner Director Regulatory Affairs, Clearance & Surveillance Building 7, No. 1510 Chuanqiao Road CHINA (SHANGHAI) PILOT FREE TRADE ZONE, 201206 CN

Re: K193574

Trade/Device Name: Q-Rad System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, LLZ, MQB Dated: December 20, 2019 Received: December 23, 2019

Dear Carolyn Wagner:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/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,

Thalia Mills, Ph.D. Division Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193574

Device Name Q-Rad System

Indications for Use (Describe)

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

Prescription Use (Part 21 CER 801 Subpart D)	Over-The-Counter Use (21 CER 801 Subpart C)
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Carestream

"510(k) Summary"

510(k) Owner Name:	Carestream Health, Inc.
510(k) Owner Address:	150 Verona StreetRochester, NY, 14608
510(k) Owner Phone:	585-627-6505
510(k) Owner Fax:	585-627-8802
Contact Person & Info:	Carolyn L WagnerDirector Regulatory Affairs, Clearance & Surveillancecarolyn.wagner@carestream.com585-627-6588

Date Summary Prepared:

December 20, 2019

510(k) Submitter: Carestream Health, Inc. Trade Name: Q-Rad System Device: System, X-Ray, Stationary Regulation Description: Stationary x-ray system Review Panel: Radiology Product Code: KPR Regulation Number: 21 CFR 892.1680 Device Class: II

Predicate 510(k) Submitter: Quantum Medical Imaging Division of Carestream Health, Inc. Predicate Trade Name: Quantum / Canon CXDI Integration System, Model QG-DIG-Predicate 510(k) Number: K080905 Device: System, X-Ray, Stationary Regulation Description: Stationary x-ray system Review Panel: Radiology Product Code: LLZ; KPR; MQB Regulation Number: 21 CFR 892.2050 / 21 CFR 892.1680 / 21 CFR 892.1650 Device Class: II Device Description:

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receptors/detectors for upright imaging, tube supports (ceiling-suspended or floormounted), x-ray tube, and collimator (beam-limiting device).

The modified (subject) device is the previously cleared Q-Rad System stationary x-ray system which has been modified as follows:

Integration of the FDA-Cleared ImageView Software (K163203) with the Q-Rad ● System.
A circuit board (CIB+ Board) has been implemented on the Q-Rad System to ● facilitate a new communication protocol between the ImageView Software and the generator.
The QMI (Quantum Medical Imaging) high voltage generator has been replaced with a Carestream-designed high voltage generator.
The VacuTec Dose Area Product (DAP) meter Model 1560015 has been replaced ● with an equivalent DAP from a different supplier, the IBA Kermax plus with Ethernet interface 120-131 ETH (Standard Size).
The Generator Control Box has been replaced. This control box is used to switch ● the generator on and off. Changes to the control box are cosmetic only and do not impact its functionality.

Indications for Use / Intended Use:

The Indications for Use Statement for the O-Rad System (also sold under the brand name "DRX-Ascend System") as described in its labeling is:

"The Q-Rad Radiographic System is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The Q-Rad System is not indicated for use in mammography."

The intended use for this device, as determined by descriptions and the proposed labeling contained in this submission, is similar to the Indications for Use statement provided above.

The Indications for Use for the subject device is the identical to that of the predicate device and the intended use remains unchanged.

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Substantial Equivalence:

Based upon information provided within this submission, we believe that the modified Q-Rad System is substantially equivalent to the legally marketed Quantum / Canon CXDI Integration System, Model QG-DIG-CXDI (predicate device).

In accordance with FDA Final Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued July 28, 2014, the critical decision points outlined in the proposed 510(k) Decision-Making Flowchart in Appendix A have been considered. The proposed predicate device, Quantum / Canon CXDI Integration System. Model OG-DIG-CXDI. has been found substantially equivalent by FDA through the 510(k) process (K080905) and is legally marketed. The Indications for Use for the subject device are identical to the predicate indications and can therefore be considered for substantial equivalence.

Risk assessment of the modifications to the Q-Rad System described in this submission has not identified any new unmitigated risks for the system. Testing to recognized prevailing consensus standards and bench testing have indicated equivalent safety and performance of the modified device. We believe that the modifications to the Q-Rad System do not raise new issues of safety and effectiveness and therefore support a substantial equivalence determination.

Discussion of Testing

The performance characteristics and operation / usability of the modified O-Rad System were evaluated in non-clinical (bench) testing. These studies have demonstrated the intended workflow, related performance, overall function, verification and validation of requirements for intended use, and reliability of the system software requirements. Nonclinical test results have demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.