Flat Panel Detector
Device Facts
| Record ID | K201591 |
|---|---|
| Device Name | Flat Panel Detector |
| Applicant | Ka Imaging, Inc. |
| Product Code | MQB · Radiology |
| Decision Date | Sep 3, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
Indications for Use
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 Story
Reveal 35C is a portable digital flat panel detector (FPD) for general radiography; integrates with PC workstation and X-ray source. Input: X-ray radiation captured by three stacked amorphous silicon active matrix arrays with cesium iodide scintillators. Operation: arrays read simultaneously and combined additively to produce standard digital images; optional dual-energy subtraction mode uses spectral differences between layers to compute and output three images (standard, bone-only, soft-tissue-only) from a single 120kVp exposure. Used in clinical settings by physicians/technologists. Output: digital images transmitted via wired/wireless connection to workstation for display. Benefit: enables material-specific visualization (bone vs. soft tissue) without requiring multiple exposures or motion-correction algorithms.
Clinical Evidence
Bench testing only. Device hardware and software requirements verified against specifications. Image quality validation confirmed equivalence to predicate devices. Adherence to IEC 60601-1 and IEC 60601-1-2 standards demonstrated.
Technological Characteristics
Amorphous silicon active matrix array with cesium iodide scintillator; 140-micron pixel pitch; 2500 x 3052 matrix; 16-bit dynamic range. Three-layer stacked sensor design. Battery-powered; wireless/wired connectivity. Dimensions: 38 x 46 x 1.5 cm; weight: 3.2 kg. Operates on Windows PC workstation.
Indications for Use
Indicated for general projection radiographic imaging of human anatomy. Not indicated for mammography, fluoroscopy, tomography, or angiography.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Yushan X-Ray Flat Panel Detector (K191939)
Reference Devices
- Carestream DRX-1 System (K150766)
- FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION (K122454)
- GE DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION (K013481)
Submission Summary (Full Text)
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September 3, 2020
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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)
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.
| 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 Panel<br>Detector | InnoCare<br>Optoelectronics Corp. | Primary<br>Predicate<br>Device |
| K150766 | Carestream DRX-1 System | Carestream Health, Inc. | Reference<br>Predicate<br>Device |
| K122454 | FUJIFILM DUAL ENERGY<br>SUBTRACTION (DES)<br>SOFTWARE OPTION | FUJIFILM MEDICAL<br>SYSTEM U.S.A., INC. | Reference<br>Predicate<br>Device |
| K013481 | DUAL ENERGY AND<br>TISSUE EQUALIZATION<br>SOFTWARE OPTION | GE MEDICAL<br>SYSTEMS | Reference<br>Predicate<br>Device |
#### IV. 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-
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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.
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.
#### V. INDICATIONS FOR USE
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 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 Reveal<br>35C Flat Panel<br>Detector | InnoCare<br>Optoelectronics<br>Yushan X-Ray Flat<br>Panel Detector<br>(K191939) | Carestream DRX-1<br>System<br>(K150766) |
| Indication for Use | The flat panel<br>detector when used<br>with a radiographic<br>imaging system is<br>intended to<br>generate<br>radiographic<br>images of human<br>anatomy wherever<br>a conventional | The Wireless/Wired<br>InnoCare Yushan<br>X-Ray Flat Panel<br>Detector is intended<br>to capture for<br>display radiographic<br>images of human<br>anatomy. It is<br>intended for use in<br>general projection | The device is<br>intended to capture<br>for display<br>radiographic<br>images of human<br>anatomy including<br>both pediatric and<br>adult patients. The<br>device is intended<br>for use in general |
| | | | |
| | screen-film, digital<br>radiography (DR) or<br>computed<br>radiography (CR)<br>detector is used for<br>general purposes.<br><br>When the dual<br>energy function is<br>enabled, it is<br>intended to assist<br>the physician<br>through the<br>visualization of<br>anomalies by<br>reducing the<br>visibility of<br>underlying or<br>overlying<br>anatomical<br>structures.<br><br>This device is not<br>intended for use in<br>mammography<br>applications. | radiographic<br>applications<br>wherever<br>conventional<br>film/screen or CR<br>systems may be<br>used. The InnoCare<br>Yushan X-Ray<br>Flat Panel Detector<br>is not intended for<br>mammography,<br>fluoroscopy,<br>tomography, and<br>angiography<br>applications. | projection<br>radiographic<br>applications<br>wherever<br>conventional<br>screen-film<br>systems or CR<br>systems may be<br>used. Excluded<br>from the indications<br>for use are<br>mammography,<br>fluoroscopy, and<br>angiography<br>applications. |
| Detector Type | Flat Panel detector<br>with scintillator | Flat Panel detector<br>with scintillator | Flat Panel detector<br>with scintillator |
| Image Capture<br>Area | 35cm x 43 cm | 35cm x 43 cm | 35cm x 43 cm |
| Detector Device<br>Material | Amorphous Silicon<br>Sensor Array with<br>Cesium lodide<br>scintillator | Amorphous Silicon<br>Sensor Array with<br>Cesium lodide or<br>Gadolinium<br>Oxisulfide<br>scintillator | Amorphous Silicon<br>Sensor Array with<br>Cesium lodide or<br>Gadolinium<br>Oxisulfide<br>scintillator |
| Pixel Pitch | 140 microns | 140 microns | 139 microns |
| Detector Element<br>Matrix | 2500 x 3052 | 2500 x 3052 | 2544 x 3056 (3543<br>GOS), 2520 x 3032<br>(3543 Csl) |
| Dynamic Range | 16 bits | 16 bits | 16 bits |
| Operating System | Windows PC | Windows PC | Windows PC |
| Operating Console | Graphical User<br>Interface Based | Graphical User<br>Interface Based | Graphical User<br>Interface Based |
| Image<br>Transmission | Image is<br>electronically | Image is<br>electronically | Image is<br>electronically |
| | transmitted in digital<br>form through tether<br>(cable) or wireless<br>connection to a<br>computer monitor<br>for display | transmitted in digital<br>form through tether<br>(cable) or wireless<br>connection to a<br>computer monitor<br>for display | transmitted in digital<br>form through tether<br>(cable) or wireless<br>connection to a<br>computer monitor<br>for display |
| Detector<br>Dimensions | 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 | Proposed<br>Device:<br>KA Imaging<br>Reveal 35C Flat<br>Panel Detector | Reference<br>Predicate Device:<br>Fujifilm Dual<br>Energy Subtraction<br>(DES) Software<br>Option (K122454) | Reference<br>Predicate<br>Device:<br>GE Dual Energy<br>And Tissue<br>Equalization<br>Software Option<br>(K013481) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use | The flat panel<br>detector when<br>used with a<br>radiographic<br>imaging system<br>is intended to<br>generate<br>radiographic<br>images of human<br>anatomy<br>wherever a<br>conventional<br>screen-film,<br>digital<br>radiography (DR)<br>or computed<br>radiography (CR)<br>detector is used<br>for general<br>purposes.<br>When the dual<br>energy function is<br>enabled, it is<br>intended to assist<br>the physician<br>through the<br>visualization of<br>anomalies by<br>reducing the<br>visibility of<br>underlying or<br>overlying<br>anatomical<br>structures. | Fujifilm's FDR Dual<br>Energy Subtraction<br>(DES) Option may<br>be used with<br>Fujifilm's DR X-ray<br>systems and is<br>intended to be used<br>by a<br>qualified/trained<br>doctor or<br>technologist for<br>acquiring dual<br>energy subtraction<br>images of human<br>anatomy<br>DES is intended to<br>assist the physician<br>through the<br>visualization of<br>anomalies by<br>reducing the<br>visibility of<br>underlying/overlying<br>anatomical<br>structures<br>The device is not<br>intended for<br>mammographic<br>applications | Dual Energy and<br>Tissue<br>Equalization<br>software options<br>are intended for<br>use in generating<br>digital<br>radiographic<br>images of human<br>anatomy. This<br>device is not<br>intended for<br>mammographic<br>applications. |
| | This device is not<br>intended for use<br>in mammography<br>applications. | | |
| Number of x-ray<br>exposures | 1 | 2 | 2 |
| Active imager<br>matrix arrays | 3 | 1 | 1 |
| X-ray beam<br>energies | 120kVp | 60 kVp/120kVp | 60 kVp/120kVp |
| Automatic Image<br>Subtraction | Yes | Yes | Yes |
| Involuntary<br>patient motion<br>reduction | Not required | Yes | Yes |
| Images sent to<br>destination | 3 Images<br>(Standard, Bone<br>and Soft Tissue) | 3 Images<br>(Standard, Bone<br>and Soft Tissue) | 3 Images<br>(Standard, Bone<br>and 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.
