The flat panel detector when used with a radiographic imaging system is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.

When the dual energy subtraction is enabled, it is intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying or overlying anatomical structures.

This device is not intended for use in mammography applications.

Device Description

The Reveal 35C Flat Panel Detector is similar to the FDA cleared Yushan X-ray Flat Panel Detector. The detectors consist of amorphous silicon flat panel image sensors with cesium iodide scintillators. The light is captured by an amorphous silicon photodetector and the resulting signal is transferred via amorphous silicon thin film transistor (TFT) switches to external readout electronics to obtain X-ray images. The Reveal 35C Flat Panel Detector is a portable digital detector that can be integrated with a PC workstation and an X-ray source to acquire digital X-Ray images for general radiography. The detector supports wireless and wired data communication and can be used wherever a conventional screen-film, digital radiography, or computed radiography detector is used for general purposes.

The Reveal 35C Flat Panel Detector synchronize their image capture cycle with the X-Ray exposure in either of the two modes:

1. Wired Mode
Wireless Mode 2.

The subject device, Reveal 35C Flat Panel Detector includes an optional Dual-Energy subtraction function. When the Dual-Energy Subtraction function is enabled, it will provide additional dual energy subtracted X-ray images. The images are intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying or overlying anatomical structures.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the KA Imaging Reveal 35C Flat Panel Detector, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria or quantitative performance metrics for the Reveal 35C Flat Panel Detector. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, design features, operating principles, functional and performance characteristics, and intended uses.

The text states that:

Non-clinical bench testing has determined that the device hardware and software requirements conform to its specification. (A general statement of performance.)
The image quality validation confirmed that the image quality of KA Imaging Reveal 35C Flat Panel Detector is substantially equivalent to that of the predicate device. (A comparative statement.)

Therefore, a table cannot be constructed with specific numerical acceptance criteria and reported device performance directly from this document. The "acceptance criteria" here is implicitly that the device performs equivalently to the listed predicate devices in its general function and image quality.

Study Information:

Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "non-clinical bench testing" and "image quality validation" but no details on patient data or specific test sets for clinical performance.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document.
Adjudication Method for the Test Set:
- This information is not provided in the document.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- An MRMC comparative effectiveness study is not mentioned in the document. There is no information about human readers improving with or without AI assistance, as the focus is on the device's technical equivalence rather than a clinical reader study of the dual-energy subtraction feature.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- The document implies that the device's dual-energy subtraction function produces images (soft-tissue and bone) that are "equivalent to those of reference predicate devices (K122454 and K013481)." This suggests a standalone comparison of the image output itself, but details of a formal standalone performance study are not explicitly described. The text states the images are "intended to assist the physician," but doesn't quantify this assistance through a standalone algorithm performance metric.
Type of Ground Truth Used:
- The document does not explicitly state the type of ground truth used for any evaluations. Given the focus on image quality equivalence and the absence of clinical outcome studies, it's likely that technical image quality metrics and visual comparison to predicate devices' outputs formed the basis of "validation," but specific ground truth types (e.g., pathology, clinical outcomes) are not mentioned.
Sample Size for the Training Set:
- The document does not provide any information regarding the sample size for a training set. This is not uncommon for 510(k) submissions that focus on device equivalence rather than novel AI/ML algorithm performance where extensive training data details are typically required.
How the Ground Truth for the Training Set Was Established:
- Since no training set is mentioned, this information is not provided.

Summary

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September 3, 2020

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional, and they are easily recognizable.

KA Imaging Inc. % Amol Karnick QA/RA Representative 560 Parkside Dr #3 Waterloo, Ontario N2L 5Z4 CANADA

Re: K201591

Trade/Device Name: Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: June 10, 2020 Received: June 12, 2020

Dear Amol Karnick:

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)

K201591

Device Name Flat Panel Detector

Indications for Use (Describe)

When the dual energy subtraction is enabled, it is intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying or overlying anatomical structures.

This device is not intended for use in mammography applications.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows a logo with the letters 'KA' stacked on top of the word 'IMAGING'. The 'K' is blue, and the 'A' transitions from blue to yellow. The word 'IMAGING' is in a bold, sans-serif font and is also yellow. The logo is simple and modern, with a clean design.

510(k) Summary

SUBMITTER l.

KA Imaging Inc. 560 Parkside Dr #3, Waterloo, ON Canada N2L 5Z4 Phone: +1 (226)-215-9897 Email: sto@kaimaging.com Contact Person: Samuel To Position: QA/RA Representative Date of Submission: June 10, 2020

II. DEVICE

Common name: Flat Panel Detector Model name: Reveal 35C Device Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) Review Panel: Radiology Product code: MQB Requlation number: 21 CFR 892.1680 Device class: Class 2

lll. PREDICATE DEVICE

Substantial equivalence to the following predicate devices is as follow:

510(k) #	Product	Company	Reference
K191939	Yushan X-Ray Flat PanelDetector	InnoCareOptoelectronics Corp.	PrimaryPredicateDevice
K150766	Carestream DRX-1 System	Carestream Health, Inc.	ReferencePredicateDevice
K122454	FUJIFILM DUAL ENERGYSUBTRACTION (DES)SOFTWARE OPTION	FUJIFILM MEDICALSYSTEM U.S.A., INC.	ReferencePredicateDevice
K013481	DUAL ENERGY ANDTISSUE EQUALIZATIONSOFTWARE OPTION	GE MEDICALSYSTEMS	ReferencePredicateDevice

IV. DEVICE DESCRIPTION

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Image /page/4/Picture/1 description: The image shows a logo for KA Imaging. The logo consists of the letters "KA" stacked on top of each other. The "K" is blue, and the "A" is yellow. Below the letters, the word "IMAGING" is written in orange. The logo is simple and modern.

Ray images for general radiography. The detector supports wireless and wired data communication and can be used wherever a conventional screen-film, digital radiography, or computed radiography detector is used for general purposes.

The Reveal 35C Flat Panel Detector synchronize their image capture cycle with the X-Ray exposure in either of the two modes:

1. Wired Mode
Wireless Mode 2.

V. INDICATIONS FOR USE

When the dual energy subtraction function is enabled, it is intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying or overlying anatomical structures.

This device is not intended for use in mammography applications.

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Image /page/5/Picture/1 description: The image shows the logo for KA Imaging. The logo consists of the letters "KA" stacked on top of the word "IMAGING". The "K" is blue, and the "A" is a gradient that transitions from blue to yellow. The word "IMAGING" is in orange.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

KA Reveal 35C device is an X-ray flat panel detector (FPD) equivalent to its indicated predicate devices. Like the predicate devices, Reveal 35C is able to capture radiographic images in a medical diagnostic setting thanks to its amorphous silicon active matrix array with an overlying cesium iodide scintillator laver. It also contains a graphical user interface software that allows for FPD operation, image processing and image display, similar to that of the identified predicate devices. Reveal 35C is therefore equivalent to its predicate devices with respect to form-factor and operation.

Unlike its predicate devices. Reveal 35C is composed of three (3) stacked active matrix arrays. Each array has its own substrate, TFT/photo-diode layer and scintillator layer. These arrays are simultaneously read and are then additively combined to generate a single image. This additive image is always digitally stored and transferred for viewing. This single image is equivalent to the single image obtained by any of the listed predicate devices, thus making Reveal 35C's image output equivalent to those devices.

Additionally, Reveal 35C's three-layer design allows for a Dual-Energy software option to be included with this submission. When this option is used, this software option is able to compute tissue-subtracted Dual-Energy images, thanks to the spectral differences between the different layer images. The Dual-Energy images obtained by this software option are equivalent to those of reference predicate devices (K122454 and K013481). See Table 1 below for a summary.

SE Table 1
Description	Proposed Device:	Primary Predicate Device:	Reference Predicate Device:
	KA Imaging Reveal35C Flat PanelDetector	InnoCareOptoelectronicsYushan X-Ray FlatPanel Detector(K191939)	Carestream DRX-1System(K150766)
Indication for Use	The flat paneldetector when usedwith a radiographicimaging system isintended togenerateradiographicimages of humananatomy wherevera conventional	The Wireless/WiredInnoCare YushanX-Ray Flat PanelDetector is intendedto capture fordisplay radiographicimages of humananatomy. It isintended for use ingeneral projection	The device isintended to capturefor displayradiographicimages of humananatomy includingboth pediatric andadult patients. Thedevice is intendedfor use in general

	screen-film, digitalradiography (DR) orcomputedradiography (CR)detector is used forgeneral purposes.When the dualenergy function isenabled, it isintended to assistthe physicianthrough thevisualization ofanomalies byreducing thevisibility ofunderlying oroverlyinganatomicalstructures.This device is notintended for use inmammographyapplications.	radiographicapplicationswhereverconventionalfilm/screen or CRsystems may beused. The InnoCareYushan X-RayFlat Panel Detectoris not intended formammography,fluoroscopy,tomography, andangiographyapplications.	projectionradiographicapplicationswhereverconventionalscreen-filmsystems or CRsystems may beused. Excludedfrom the indicationsfor use aremammography,fluoroscopy, andangiographyapplications.
Detector Type	Flat Panel detectorwith scintillator	Flat Panel detectorwith scintillator	Flat Panel detectorwith scintillator
Image CaptureArea	35cm x 43 cm	35cm x 43 cm	35cm x 43 cm
Detector DeviceMaterial	Amorphous SiliconSensor Array withCesium lodidescintillator	Amorphous SiliconSensor Array withCesium lodide orGadoliniumOxisulfidescintillator	Amorphous SiliconSensor Array withCesium lodide orGadoliniumOxisulfidescintillator
Pixel Pitch	140 microns	140 microns	139 microns
Detector ElementMatrix	2500 x 3052	2500 x 3052	2544 x 3056 (3543GOS), 2520 x 3032(3543 Csl)
Dynamic Range	16 bits	16 bits	16 bits
Operating System	Windows PC	Windows PC	Windows PC
Operating Console	Graphical UserInterface Based	Graphical UserInterface Based	Graphical UserInterface Based
ImageTransmission	Image iselectronically	Image iselectronically	Image iselectronically
	transmitted in digitalform through tether(cable) or wirelessconnection to acomputer monitorfor display	transmitted in digitalform through tether(cable) or wirelessconnection to acomputer monitorfor display	transmitted in digitalform through tether(cable) or wirelessconnection to acomputer monitorfor display
DetectorDimensions	38 x 46 x 1.5 cm	38.3 x 46 x 1.5 cm	38 x 46 x 1.6 cm
Detector Weight	3.2 kg	2.7 Kg	4 kg
Power Source	Battery powered	Battery powered	Battery powered
Communication	Wireless/ Wired	Wireless/ Wired	Wireless/ Wired

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Image /page/6/Picture/1 description: The image shows a logo for KA Imaging. The logo consists of the letters 'KA' stacked on top of the word 'IMAGING'. The 'K' is blue, and the 'A' transitions from blue to yellow. The word 'IMAGING' is in orange.

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Image /page/7/Picture/1 description: The image shows a logo for KA Imaging. The logo features the letters "KA" stacked on top of the word "IMAGING". The "K" is blue, and the "A" is a gradient from blue to yellow. The word "IMAGING" is in yellow and is located directly below the letters "KA".

The KA Imaging Reveal 35C Flat Panel Detector also includes a dual energy subtraction software option, which can be used to optionally generate three types of radiographic images from a single X-Ray exposure. The first is a (1) standard projection radiography image, equivalent to the primary and reference predicate device (K150766). The second and third images are a (2) soft-tissue image with the bone information removed, and a (3) bone image with the soft tissue information removed. The second image and third image allow the radiologist to subtract specific materials (e.g. bone, soft tissue) and focus on the tissue-type of choice, thus increasing the visualization of the objects of interest.

The reference predicate devices Fujifilm Dual Energy Subtraction (DES) Software Option (K122454) and GE Dual Energy And Tissue Equalization Software Option (K013481) are both software options to provide Dual Energy subtracted images. For both K122454 and K013481, two spectral source images are obtained using two X-ray exposures (the first exposure at a lower kV (typically 60kV) and the second exposure at a higher kV (typically 120kV)). For Reveal 35C, the spectral source images are generated from only a single kV(typically 120kV) exposure because of the use of three active matrix arrays in the Reveal 35C design. Since only a single exposure is utilized for Reveal 35C, there is no additional software required to correct for the involuntary motion artifacts described in K122454. Please see the summary in Table 2 below:

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Image /page/8/Picture/1 description: The image shows the logo for KA Imaging. The logo consists of the letters "KA" stacked on top of the word "IMAGING". The "K" is blue, and the "A" is a gradient that transitions from blue to yellow. The word "IMAGING" is in orange.

SE Table 2

Description	ProposedDevice:KA ImagingReveal 35C FlatPanel Detector	ReferencePredicate Device:Fujifilm DualEnergy Subtraction(DES) SoftwareOption (K122454)	ReferencePredicateDevice:GE Dual EnergyAnd TissueEqualizationSoftware Option(K013481)
Indication forUse	The flat paneldetector whenused with aradiographicimaging systemis intended togenerateradiographicimages of humananatomywherever aconventionalscreen-film,digitalradiography (DR)or computedradiography (CR)detector is usedfor generalpurposes.When the dualenergy function isenabled, it isintended to assistthe physicianthrough thevisualization ofanomalies byreducing thevisibility ofunderlying oroverlyinganatomicalstructures.	Fujifilm's FDR DualEnergy Subtraction(DES) Option maybe used withFujifilm's DR X-raysystems and isintended to be usedby aqualified/traineddoctor ortechnologist foracquiring dualenergy subtractionimages of humananatomyDES is intended toassist the physicianthrough thevisualization ofanomalies byreducing thevisibility ofunderlying/overlyinganatomicalstructuresThe device is notintended formammographicapplications	Dual Energy andTissueEqualizationsoftware optionsare intended foruse in generatingdigitalradiographicimages of humananatomy. Thisdevice is notintended formammographicapplications.
	This device is notintended for usein mammographyapplications.
Number of x-rayexposures	1	2	2
Active imagermatrix arrays	3	1	1
X-ray beamenergies	120kVp	60 kVp/120kVp	60 kVp/120kVp
Automatic ImageSubtraction	Yes	Yes	Yes
Involuntarypatient motionreduction	Not required	Yes	Yes
Images sent todestination	3 Images(Standard, Boneand Soft Tissue)	3 Images(Standard, Boneand Soft Tissue)	3 Images(Standard, Boneand Soft Tissue)

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Image /page/9/Picture/1 description: The image shows a logo for KA Imaging. The logo features the letters "KA" in a stylized design, with the "K" in blue and the "A" transitioning from blue to yellow. Below the letters, the word "IMAGING" is written in a bold, sans-serif font, also in yellow. The overall design is clean and modern.

VII. PERFORMANCE DATA

Non-clinical Performance Data

The Reveal 35C Flat Panel Detector conforms to the voluntary standards including IEC 60601-1 and IEC 60601-1-2. Non-clinical bench testing has determined that the device hardware and software requirements conform to its specification.

FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (issued on September 1, 2016), Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, were followed to demonstrated that the performance of Reveal 35C Flat Panel Detector is substantially equivalent to the predicate devices.

Furthermore, the image quality validation confirmed that the image quality of KA Imaging Reveal 35C Flat Panel Detector is substantially equivalent to that of the predicate device.

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Image /page/10/Picture/1 description: The image shows a logo for KA Imaging. The logo features the letters 'KA' in a stylized design, with the 'K' in blue and the 'A' in yellow. Below the letters, the word 'IMAGING' is written in yellow, completing the logo.

CONCLUSIONS VIII.

The Reveal 35C Flat Panel Detector is substantially equivalent to the predicate devices in technical characteristics, design features, operating principles, functional and performance characteristics, and for the intended uses.

The Reveal 35C Flat Panel Detector is designed to comply with applicable federal and international safety and performance standards.

Based upon the supporting data summarized above, we can conclude the subject device is substantially equivalent in safety and effectiveness as the legally marketed devices. The verification and validation activities performed on the subject device did not raise any issues related to safety and effectiveness.

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.