(83 days)
No
The summary describes a flat panel detector and a dual-energy subtraction function, which is a standard image processing technique, not AI/ML. There is no mention of AI, ML, or related concepts like training or test sets for algorithmic performance.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is an X-ray flat panel detector used for generating images for diagnostic purposes, not for treatment or prevention.
Yes
Explanation: The device is a "Flat Panel Detector" that generates "radiographic images of human anatomy." It also has an optional "Dual-Energy subtraction function" that provides "additional dual energy subtracted X-ray images" intended to "assist the physician through the visualization of anomalies by reducing the visibility of underlying or overlying anatomical structures." This function for visualizing anomalies directly supports diagnosis.
No
The device description clearly details physical hardware components like amorphous silicon flat panel image sensors, cesium iodide scintillators, photodetectors, and TFT switches, indicating it is a hardware device with associated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- This device is a flat panel detector used in a radiographic imaging system to generate X-ray images of human anatomy in vivo (within the body). It captures X-rays that have passed through the patient's body.
The device's function is to acquire images of internal structures, which is a core function of medical imaging devices, not IVDs. While the images are used by a physician to assist in diagnosis, the device itself is not performing a diagnostic test on a biological sample.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB
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:
-
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known)
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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3
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 | ||
| Detector | InnoCare | ||
| Optoelectronics Corp. | Primary | ||
| Predicate | |||
| Device | |||
| K150766 | Carestream DRX-1 System | Carestream Health, Inc. | Reference |
| Predicate | |||
| Device | |||
| K122454 | FUJIFILM DUAL ENERGY | ||
| SUBTRACTION (DES) | |||
| SOFTWARE OPTION | FUJIFILM MEDICAL | ||
| SYSTEM U.S.A., INC. | Reference | ||
| Predicate | |||
| Device | |||
| K013481 | DUAL ENERGY AND | ||
| TISSUE EQUALIZATION | |||
| SOFTWARE OPTION | GE MEDICAL | ||
| SYSTEMS | Reference | ||
| Predicate | |||
| 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-
4
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:
-
- 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.
5
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 | |||
| 35C Flat Panel | |||
| Detector | InnoCare | ||
| Optoelectronics | |||
| Yushan X-Ray Flat | |||
| Panel Detector | |||
| (K191939) | Carestream DRX-1 | ||
| System | |||
| (K150766) | |||
| Indication 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 | The Wireless/Wired | ||
| InnoCare Yushan | |||
| X-Ray Flat Panel | |||
| Detector is intended | |||
| to capture for | |||
| display radiographic | |||
| images of human | |||
| anatomy. It is | |||
| intended for use in | |||
| general projection | The device is | ||
| intended to capture | |||
| for display | |||
| radiographic | |||
| images of human | |||
| anatomy including | |||
| both pediatric and | |||
| adult patients. The | |||
| device is intended | |||
| for use in general | |||
| screen-film, digital | |||
| radiography (DR) or | |||
| computed | |||
| radiography (CR) | |||
| detector is used for | |||
| general purposes. |
When the dual
energy 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. | radiographic
applications
wherever
conventional
film/screen or CR
systems may be
used. The InnoCare
Yushan X-Ray
Flat Panel Detector
is not intended for
mammography,
fluoroscopy,
tomography, and
angiography
applications. | projection
radiographic
applications
wherever
conventional
screen-film
systems or CR
systems may be
used. Excluded
from the indications
for use are
mammography,
fluoroscopy, and
angiography
applications. |
| Detector Type | Flat Panel detector
with scintillator | Flat Panel detector
with scintillator | Flat Panel detector
with scintillator |
| Image Capture
Area | 35cm x 43 cm | 35cm x 43 cm | 35cm x 43 cm |
| Detector Device
Material | Amorphous Silicon
Sensor Array with
Cesium lodide
scintillator | Amorphous Silicon
Sensor Array with
Cesium lodide or
Gadolinium
Oxisulfide
scintillator | Amorphous Silicon
Sensor Array with
Cesium lodide or
Gadolinium
Oxisulfide
scintillator |
| Pixel Pitch | 140 microns | 140 microns | 139 microns |
| Detector Element
Matrix | 2500 x 3052 | 2500 x 3052 | 2544 x 3056 (3543
GOS), 2520 x 3032
(3543 Csl) |
| Dynamic Range | 16 bits | 16 bits | 16 bits |
| Operating System | Windows PC | Windows PC | Windows PC |
| Operating Console | Graphical User
Interface Based | Graphical User
Interface Based | Graphical User
Interface Based |
| Image
Transmission | Image is
electronically | Image is
electronically | Image is
electronically |
| | transmitted in digital
form through tether
(cable) or wireless
connection to a
computer monitor
for display | transmitted in digital
form through tether
(cable) or wireless
connection to a
computer monitor
for display | transmitted in digital
form through tether
(cable) or wireless
connection to a
computer monitor
for display |
| Detector
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
Device:
KA Imaging
Reveal 35C Flat
Panel Detector | Reference
Predicate Device:
Fujifilm Dual
Energy Subtraction
(DES) Software
Option (K122454) | Reference
Predicate
Device:
GE Dual Energy
And Tissue
Equalization
Software Option
(K013481) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication 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 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. | Fujifilm's FDR Dual
Energy Subtraction
(DES) Option may
be used with
Fujifilm's DR X-ray
systems and is
intended to be used
by a
qualified/trained
doctor or
technologist for
acquiring dual
energy subtraction
images of human
anatomy
DES is intended to
assist the physician
through the
visualization of
anomalies by
reducing the
visibility of
underlying/overlying
anatomical
structures
The device is not
intended for
mammographic
applications | Dual Energy and
Tissue
Equalization
software options
are intended for
use in generating
digital
radiographic
images of human
anatomy. This
device is not
intended for
mammographic
applications. |
| | This device is not
intended for use
in mammography
applications. | | |
| Number of x-ray
exposures | 1 | 2 | 2 |
| Active imager
matrix arrays | 3 | 1 | 1 |
| X-ray beam
energies | 120kVp | 60 kVp/120kVp | 60 kVp/120kVp |
| Automatic Image
Subtraction | Yes | Yes | Yes |
| Involuntary
patient motion
reduction | Not required | Yes | Yes |
| Images sent to
destination | 3 Images
(Standard, Bone
and Soft Tissue) | 3 Images
(Standard, Bone
and Soft Tissue) | 3 Images
(Standard, Bone
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.