The PowerDR™ Digital X-ray Imaging System is indicated for use as an X-ray imaging modality to acquire, process, display, quality assure and store digital medical X-ray images.

The PowerDR™ Digital X-ray Imaging System is indicated for use in general radiographic and fluoroscopic examinations of any anatomy for adult, pediatric, and neonatal patients. It is not indicated for use in mammography.

Device Description

The PowerDR™ Console Application is a digital medical X-ray imaging system consisting of an X-Ray detector, computer hardware and the PowerDR™ software. The User supplies the X-Ray generator. The PowerDR™ Console Application is intended to enable a procedure of medical image acquisition, processing, display, quality assurance, and storage. The software interfaces to an X-Ray detector from variety of vendors to acquire raw pixel data. Its image-processing algorithms transform raw pixel data into diagnostic quality images and image sequences to aid the medical professional in diagnosis. For temporary storage, image data can be stored on the local computer. For long term storage, image data can be stored on a portable media device or a remote PACS (Picture Archive and Communication System) server. The PowerDR™ Digital X-ray Imaging System is intended for use in general radiographic and fluoroscopic examinations of any anatomy for adult, pediatric, and neonatal patients. It is not intended for use in mammography. The system can be sold with or without a computer, and with or without a compatible, previously cleared, digital receptor panel.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the PowerDR™ Digital X-ray Imaging System. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than proving the device meets specific performance acceptance criteria through the kind of studies typically seen for novel AI/ML devices.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for AI/ML performance.

Specifically:

No table of acceptance criteria and reported device performance is provided because this is a substantial equivalence submission, not a performance validation against defined metrics for an AI/ML component. The "performance" demonstrated is that the new device operates similarly to the predicate device in terms of image acquisition, processing, display, quality assurance, and storage.
No sample size for a test set or data provenance is mentioned in the context of an AI/ML performance study. The "test set" here refers to the validation of the system's ability to acquire and process images, not to a diagnostic performance evaluation of an AI algorithm. The document states "image inspection, bench, and test laboratory results" were used, and "Each available digital receptor panel has undergone a rigorous verification and validation procedure."
No number of experts or qualifications of experts used for ground truth establishment for a test set. This is not an AI/ML diagnostic study.
No adjudication method is mentioned, as there is no diagnostic ground truth establishment process described for an AI/ML algorithm.
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done because there is no AI assistance component to evaluate.
No standalone (algorithm only) performance study was done; the focus is on the integrated system's functionality.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) is not applicable in the context of an AI/ML performance study. The "ground truth" for this device relates to the technical specifications and image quality relative to the predicate device.
No sample size for the training set is applicable; this is not an AI/ML algorithm that undergoes a training phase as typically understood.
How the ground truth for the training set was established is not applicable for the same reason.

The core argument for the PowerDR™ system is that it is substantially equivalent to the predicate device (Nexus DRF Digital X-ray Imaging System, K130318) in terms of its intended use, technology, and safety and effectiveness. The evidence provided to support this is:

Bench testing: "The results of image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate devices."
Use of previously cleared components: All compatible digital panels supported by PowerDR™ "have previously received FDA 510(k) clearances" and "undergone a rigorous verification and validation procedure."
Compliance with FDA guidance documents: Specifically, guidance for software in medical devices, cybersecurity, and pediatric imaging information.
Comparison chart: A detailed "Substantial Equivalence Chart" (Section 5) outlining similarities in identification, intended use, description, where used, image processing, image storage, image data source, configuration, primary digital panel support (multiple for proposed vs. one for predicate, with all proposed panels being previously cleared), system software, image data format, image presentation, application software, tracking X-ray dose, fluoro image processing, MultiRad image support, dose and processing auto optimization, quality assurance, DICOM 3.0 conformance, IHE Integration profile, power source, and computer platform.

Conclusion stated in the document: "After analyzing bench testing and risk analysis and compliance to the DICOM standard, it is the conclusion of Radiology Information Systems, Inc. that the PowerDR™ Digital X-ray Imaging System is as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device."

In summary, this 510(k) submission does not describe an AI/ML device or a study validating AI/ML performance using acceptance criteria. Instead, it demonstrates substantial equivalence to a predicate device through bench testing and comparison of technical specifications.

Summary

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Radiology Information Systems, Inc. % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114

August 16, 2019

Re: K191504

Trade/Device Name: PowerDR™ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, MQB Dated: June 3, 2019 Received: June 6, 2019

Dear Mr. Kamm:

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 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

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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 mediation-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.

For

Thalia T. Mills, Ph.D. 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) K191504

Device Name PowerDR™

Indications for Use (Describe)

The PowerDR Digital X-ray Imaging System is indicated for use as an X-ray imaging modality to acquire, process, display, quality assure and store digital medical X-ray images.

The PowerDR Digital X-ray Imaging System is indicated for use in general radiographic and fluoroscopic examinations of any anatomy for adult, pediatric, and neonatal patients. It is not indicated for use in mammography.

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)

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510(k) Summary 510(k) Number K191504

Image /page/3/Picture/1 description: The image shows the logo for RADinfo SYSTEMS. The logo consists of the text "RADinfo SYSTEMS" in bold black letters, with the word "RADinfo" being larger than the word "SYSTEMS". Below the text is the tagline "Delivering Solutions that Meet Your Vision" in a smaller, lighter font. To the right of the text is a blue circular graphic with a stylized letter "R" inside.

Radiology Information Systems, Inc. 43676 Trade Center Place, Ste 100 Dulles, VA 20166 Ph: 703-713-3313 Fx: 703-713-3343 www.radinfosystems.com Contact/Prepared by: Chen-Tai Ma Ph.D. Contact Title CEO and President Date Prepared: August 9, 2019

1. Identification of the Device: Trade/Device Name: PowerDR™ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA, MQB
1. Equivalent legally marketed device: K130318, Varian Medical Systems, X-Ray Products-InfiMed Trade/Device Name: Nexus DRF Digital X-ray Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA, MQB
1. Indications for Use (intended use) The PowerDR™ Digital X-ray Imaging System is indicated for use as an Xray imaging modality to acquire, process, display, quality assure and store digital medical X-ray images. The PowerDR™ Digital X-ray Imaging System is indicated for use in general radiographic and fluoroscopic examinations of any anatomy for adult, pediatric, and neonatal patients. It is not indicated for use in mammography. (Rx Only)
1. Description of the Device: The PowerDR™ Console Application is a digital medical X-ray imaging system consisting of an X-Ray detector, computer hardware and the PowerDR™ software. The User supplies the X-Ray generator. The PowerDR™ Console Application is intended to enable a procedure of medical image acquisition, processing, display, quality assurance, and storage. The software interfaces to an X-Ray detector from variety of vendors to acquire raw pixel data. Its image-processing algorithms transform raw pixel data into diagnostic quality images and image sequences to aid the medical professional in diagnosis. For temporary storage, image data can be stored on the local computer. For long term storage, image data can be stored on a portable media device or a remote PACS (Picture Archive and Communication System) server. The PowerDR™ Digital X-ray Imaging System is intended for use in general radiographic and fluoroscopic examinations of any anatomy for adult, pediatric, and neonatal patients. It is not intended for use in mammography. The system can be sold with or without a computer, and with or without a compatible, previously cleared, digital receptor panel. The computer requirements are: Intel Core i5-8500, 6 Core, 9MB Cache, 3.0GHz, 4.1Ghz Turbo w/ HD Graphics 630, Win 10 Pro 64, 8x DVD+/-RW 9.5mm Optical Disk Drive, (2) 3.5 inch 1TB 7200rpm SATA Hard Disk Drives RAID 1, 8GB RAM, Intel Integrated Graphics, 22" display monitor 1920x1080 at 60 Hz. If the customer buys only the software, they are required to install and keep up to date one of the anti-virus programs cited in our User Manual. In addition the device conforms to the applicable provisions EPRC regulations, 21 CFR 1020.30, 1020.31, and 21 CFR 1020.32.

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1. Safety and Effectiveness, comparison to predicate device. The results of image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate devices. All of the proposed panels have previously received FDA 510(k) clearances.

5. Substantial Equivalence Chart

Characteristic	Predicate Device	Proposed Device
Identification	K130318, Varian Medical Systems, X- RayProducts-InfiMed , Trade/Device Name:Nexus DRF Digital X-ray Imaging System	RADinfo SYSTEMS, Digital X-ray ImagingProducts, Trade/Device Name:PowerDR™ Console Application
Intended Use:	The InfiMed i5 Digital X-ray ImagingSystem is a high resolution digital imagingsystem intended to replace conventionalfilm techniques, or existing digital systems,in multipurpose or dedicated applicationsspecified below. The i5 Digital X-rayImaging System enables an operator toacquire, display, process, export images toportable media, send images over anetwork for long term storage anddistribute hardcopy images with a laserprinter.	The PowerDR™ Digital X-ray ImagingSystem is indicated for use to acquire,process, display, quality assure and storedigital medical X-ray images. ThePowerDR™ Digital X-ray Imaging System isindicated for use in general radiographicand fluoroscopic examinations of anyanatomy for adult, pediatric, and neonatalpatients. It is not indicated for use inmammography.(similar)
Description	Digital image software application	Same
Where used	Radiology department and medicalimaging center use in generalradiographic examinations andapplications. For the RF/DSA application,the InfiMed i5 Digital X-ray ImagingSystem is intended for use where generalfluoroscopy, interventional fluoroscopy orangiography imaging procedures areperformed.	Radiology department and medical imagingcenter use in general radiographicexaminations and applications. For theRF/DSA application, the PowerDR™ DigitalX-ray Imaging System is intended for usewhere general fluoroscopy, interventionalfluoroscopy or angiography imagingprocedures are performed. SAME
imageprocessing	Image processing algorithms enable theoperator to bring out diagnostic detailsdifficult to see using conventional imagingtechniques.	The image processing software, usedwith a cleared DR device, providesdiagnostic quality images to aidphysicians with diagnosis.
image Storage	Images can be stored locally for temporarystorage.	Same
Image datasource	A variety of image receptors fromcommercially available flat paneldetectors.	Same
Configuration	Digital Panel, a connected personalcomputer, and installed applicationsoftware.	Same
Primary DigitalPanel	Varex/PaxScan 4343CB flat paneldetector	Multiple panels supported: Pixium;Careray; Varex/XRPad2. Only FDA clearedpanels are supported. See detailed listbelow.
Characteristic	Predicate Device	Proposed Device
SystemSoftware	Installed on a Microsoft Windows PC(Windows 10 64 bit)	Same
Imagedataformat	The input and output image pixel data isthe raster data. The photometricrepresentation of the image pixel data isprovided.	Same
Imagepresentation	Enhanced Visualization Processing(EVP)	Same
Applicationsoftware	Enhanced GUI for easy navigation	Same
TrackingXray dose	Dose recording from generator	Same
Fluoroimageprocessing	Advanced contrast and edgeenhancement	Same
MutiRad image	Support last image hold and reviewprevious frames	Same
Dose andprocessingAuto optimized	Based on selected Fluoro frames rateand magnification	Same
QualityAssurance	Support various quality assurancetools	Same
DICOM 3.0Conformance	Yes	Yes
IHEIntegrationprofile	Yes	Yes
Power source(for requiredcomputer)	120 VAC	Same
ComputerPlatform	Windows 10® 64 bit operatingsystem	Same, see computer requirements indescription above.
Manufacturer	Model Number	Static/DynamicNote: All Dynamicpanels can take StaticImages.	510(k) Number
Thales Pixium	RAD 4343	Static	K133139
Thales Pixium	RAD 4143	Static	K133139
Thales Pixium	RF 4343	Dynamic	K150306
Thales Pixium	3543 EZ	Static	K141440
Thales Pixium	2430 EZ	Static	K141440
Careray	CareView 750C	Static	K163019
Careray	CareView 750Cw	Static	K163019
Careray	CareView 1500 L	Static	K153058
Careray	CareView 1500C	Static	K153058
Careray	CareView 1500Cw	Static	K150929
Careray	CareView 1500P	Static	K162178
Careray	CareView 1800L	Static	K153492
Careray	CareView 1800Cw	Static	K172581
Varex	XRpad2 4336	Dynamic	K161966
Varex	XRpad2 3025	Dynamic	K161942

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1. Summary of Bench Testing Conducted: This is a software product installed on a PC using Windows 10® 64 bit operating system which interfaces with FDA cleared digital x-ray receptor panels. All compatible digital panels have already received FDA clearances. See list below Risk Analysis and software validation was conducted in accordance with FDA guidance documents. All panels had been tested in accordance with the FDA guidance on Solid State Imaging Devices via their previous clearances. We employed these FDA guidance documents in the development of this software product: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Guidance for Industry and FDA Staff MAY 2005; AND Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff OCTOBER 2014. We also employed FDA recommendations in our labeling regarding imaging the pediatric population: Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Druq Administration Staff, November 2017. The user manual states: "Use special care when imaging patients outside the typical adult size range. Children are more radiosensitive than adults."

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Each available digital receptor panel has undergone a rigorous verification and validation procedure prior to addition to our line-up.

List of Tested Panels

1. Summary of Clinical Testing: Clinical testing was not necessary to establish substantial equivalence. All digital panels employed have received previous FDA clearance.
1. Conclusion: After analyzing bench testing and risk analysis and compliance to the DICOM standard, it is the conclusion of Radiology Information Systems, Inc. that the PowerDR™ Digital X-ray Imaging System is as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.

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.