(49 days)
No
The document describes a standard digital radiography system that converts x-rays to digital images for viewing and manipulation. There is no mention of AI or ML algorithms being used for image analysis, diagnosis, or any other function. The performance studies focus on basic functional requirements, software verification, and safety standards, not AI/ML performance metrics.
No
The description states the device is used for diagnostic purposes by capturing and manipulating dental x-ray images, not for treating any condition or disease.
Yes
The "Intended Use / Indications for Use" states that the electronic impulses "may be stored, viewed and manipulated for diagnostic use by dentists."
No
The device description explicitly states it includes a "reusable electronic sensor" which is a hardware component, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SunilQ Digital Radiography system is an imaging device that uses X-rays to create images of dental structures. It does not analyze biological samples.
- Intended Use: The intended use is for collecting and processing dental X-ray images for diagnostic use by dentists. This is a form of medical imaging, not in vitro testing.
The device description and intended use clearly indicate that it is a medical imaging system, not an IVD.
N/A
Intended Use / Indications for Use
The SunilQ Digital Radiography system is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
Product codes
MUH
Device Description
The SuniIQ Digital Radiography System reduces x-ray exposure by producing real time digital intra-oral images. The System accomplishes this by replacing X-ray film with a reusable electronic sensor that captures the X-ray photons and converts them to an electronic signal which, in turn, is captured in a computer for viewing, manipulating, storing, and output. There are two models of the SunilQ. The only difference between the two models is the size of the sensor. The sensor sizes correspond to #1 and #2 dental film.
The SuniIQ Sensor (1) incorporates a CMOS detector for capture and imaging of x-ray photons. The sensor is encapsulated into a plastic housing and is connected via a cable to the SuniIO USB interface electronics module (2). The USB-interface has two LEDs that indicate USB power (4) and interface activity (5).
The USB Interface is connected to a USB cable using a type "mini-B" USB connector (3). The other end of this cable terminates in a USB plug (6) for connection to a USB port on the host computer.
The System also includes software drivers that control the USB interface module and a Graphical User Interface (GUI) which allows the user access to the data and to control functions of the System.
The SuniIQ is intended to be used with dedicated dental x-ray Imaging software to provide the dental professional user the benefits of "real time" imaging system. The software manufactured by Apteryx (K983111) is such dedicated dental software for dental x-ray imaging.
The System sensors are available in two formats. The #2 size (400-1322) is a larger sensor typical of the European format and the # 1 size (400-1321) is an intermediate size. The sensors consist of a CMOS type integrated circuit, and a high resolution scintillator screen that converts the photons from the X-rays into visible light, which is then acquired by the CMOS imaging integrated circuit. The sensors are encapsulated in a plastic enclosure with a three-foot cable that is connected to the USB interface electronics module.
The USB interface electronics module plugs into a computer USB port via a supplied USB cable. The USB interface electronics module contains the support and control circuitry for the sensor and allows for data communications with the computer. The USB interface electronics module contains all necessary circuits for sensor data acquisition as well as memory for firmware control of the CMOS X-ray sensor and USB. The USB interface electronics module communicates with the computer under control of a specific device driver that is active with the GUL.
The system software functions on three levels: (1) The computer operating system (Microsoft Windows) controls the computer, user interface, and file structure; (2) Primary control of the sensor and bus functions is achieved by proprietary software and is either embedded firmware or in non-user accessible drivers; and (3) A Graphical User Interface (GUI) allows the user to control the x-ray function, control of the sensor data acquisition, and image viewing. manipulation and output. Examples of the GUI include image capture, enhanced viewing features (zoom, pan, colorize, contrast/brightness, comparative analysis, etc.) image organization, and storage.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists
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)
Bench testing confirmed that the performance of the SuniIQ System meets all functional requirements. This testing included, where relevant, direct comparison to the performance of the predicate SuniRay II System.
Tested Function: Relative error, Result: Pass
Tested Function: X-Ray Saturation, Result: Pass
Tested Function: Image size, Result: Pass
Tested Function: Image orientation, Result: Pass
Tested Function: Set up time, USB current and clock pattern, Result: Pass
Tested Function: Dose loss and focus to detector distance (FDD), Result: Pass
Tested Function: Saturation Comparison, Result: Pass
Tested Function: Printed Circuit Board (PCB), Result: Pass
Tested Function: Software Development Kit (SDK), Result: Pass
Tested Function: Time to ready for exposure state, Result: Pass
Tested Function: Test Pattern Images, Result: Pass
Tested Function: Dental Phantom Images, Result: Pass
Tested Function: Other Operating systems, Result: Pass
Software V&V
Software verification & validation testing was conducted in accordance with IEC 62304:2006: Medical device software -- Software Life Cycle Processes and with FDA guidances for software development and testing (Guidance for the Content of Premarket Submission for Medical Device Containing Software, FDA-CDRH-CBER, Rockville, MD, 05/2005; Guidance for Off-the-Shelf Software Use in Medical Devices, FDA- CDRH, Rockville, MD, 06/1997; and General Principles of Software Validation; Final Guidance for Industry and FDA Staff, FDA-CDRH, Rockville, MD, 01/2002). All features provided for the SunilQ System have been verified to operate as specified. The software systems were treated as entirely new systems in respect to specification and verification to adjust the documentation and verification requirements to the current state of technology. All test passing criteria for the Software V&V were met. Both software systems were verified entirely to establish a new baseline and regression testing was therefore not indicated.
Biocompatibility
The materials of the device have been evaluated, tested, and determined to meet requirements under ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process, and the FDA draft guidance document Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (April 23, 2013).
Disinfection
The recommended cleaning method (intermediate level of disinfection) has been evaluated and confirmed. Testing was performed under Good Laboratory Practices regulations (21CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies).
Electromagnetic Compatibility and Electrical Safety
The System meets the requirements of IEC 60601-1:2005 and ANSI/AAMI ES60601-1:2005 for safety, IEC 60601-1-2:2007 for electromagnetic compatibility.
All features provided for the SunilQ System have been verified to operate as specified. Testing confirms that the SuniIQ System is as safe, as effective, and performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three wave-like lines below them. The profiles and waves are black, and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2016
Suni Medical Imaging, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K162585
Trade/Device Name: SuniIO Digital Radiography System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: October 26, 2016 Received: October 27, 2016
Dear Mr. Job:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Robert Ochs
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162585
Device Name SuniIQ Digital Radiography System
Indications for Use (Describe)
The SunilQ Digital Radiography system is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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2. 510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| DATE PREPARED | November 4, 2016 |
|---|---|
| APPLICANT | Suni Medical Imaging, Inc. |
| 6840 Via Del Oro, Suite #160 | |
| San Jose, CA 95119 | |
| www.suni.com | |
| Tel: (408) 227-6698 | |
| OFFICIAL | |
| CORRESPONDENT | Al Bettencourt |
| Suni Medical Imaging, Inc. | |
| 6840 Via Del Oro, Suite #160 | |
| San Jose, CA 95119 | |
| Al.Bettencourt@suni.com | |
| Tel: (408) 337-0573 | |
| Fax: (408) 227-9304 | |
| TRADE NAME | SuniIQ Digital Radiography System |
| COMMON NAME | Digital Extraoral Source X-Ray System |
| MODEL NUMBERS | 400-1321 SuniIQ Size 1 |
| 400-1322 SuniIQ Size 2 | |
| DEVICE CLASSIFICATION | Name: Extraoral source x-ray system |
| Regulation No: 21 CFR $§872.1800$ | |
| Product Code: MUH | |
| Class: II | |
| Panel: Radiology | |
| PREDICATE DEVICE | SuniRay II Digital Radiography System - K070219 |
SUBSTANTIALLY EQUIVALENT TO:
The SuniIQ Digital Radiography System is substantially equivalent in intended use and technological features to the SuniRay II Digital Radiography System (K070219).
SUMMARY OF SIMILARITIES / DIFFERENCES:
The SuniIQ Digital Radiography system shares the same design features as the predicate device and does not introduce any new technological characteristics. Following are the shared features:
Both devices convert x-rays to digital images using an indirect x-ray detector:
4
SECTION 2.
- . The scintillator converts x-ray energy into visible light in proportion to the x-ray energy received.
- A fiber optic plate coupled to the scintillator passes the visible light to the CMOS (complementary metal-oxide semiconductor) sensor while blocking x-ray energy.
- The visible light is captured by the circuitry of the CMOS sensor, converting visible light into an electrical signal proportional to the visible light received.
- An analog to digital converter processes the signal prior to transfer to the host computer via the USB cable.
The primary difference between the two devices is that the CMOS in the SuniIQ incorporates an improved pixel design that increases the surface area of the transistors, which supports increasing the pixel voltage resetting value from 2.9 V to 3.5 V. This allows more x-ray converted charge to be integrated into each pixel, resulting in a 30% increase in x-ray exposure range over the SuniRay II. The SunilO also incorporates an improved system for image correction compared to the SuniRayII, with a 2D fault correction map that is derived from characterization of each pixel. Finally, the outer jacket of the sensor incorporates a green colorant; the outer jacket of the predicate SuniRayII has a black colorant.
The software components of the SuniIO (SuniIO USB software version 2.0 and SuniIQ Driver SDK version 10.0.1.2) provide the features of the software components of the predicate device, and add the functionality of a new sensor type and an optional filter algorithm. As with the predicate device, the software does not incorporate a Graphical User Interface (GUI) or other user-controlled image processing/viewing functionality.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The SuniIQ Digital Radiography System reduces x-ray exposure by producing real time digital intra-oral images. The System accomplishes this by replacing X-ray film with a reusable electronic sensor that captures the X-ray photons and converts them to an electronic signal which, in turn, is captured in a computer for viewing, manipulating, storing, and output.
Image /page/4/Picture/10 description: The image shows a Suni digital radiography system. The system includes a sensor with a white and green housing labeled "suni iq" (1), a black cable, and a black sensor body labeled "suni" (2). The sensor body has a connector (4) for a cable with a micro-USB connector (3) on one end and a USB-A connector (6) on the other end. There is a small hole on the sensor body (5).
5
There are two models of the SunilQ. The only difference between the two models is the size of the sensor. The sensor sizes correspond to #1 and #2 dental film.
| Model | Sensor Dimensions
(mm) | Active Area
(mm) |
|-------------------|---------------------------|---------------------|
| 400-1321 – Size 1 | 39.5 x 26 | 31.1 x 20.2 |
| 400-1322 – Size 2 | 43.5 x 31.5 | 35.2 x 26.2 |
The SuniIQ Sensor (1) incorporates a CMOS detector for capture and imaging of x-ray photons. The sensor is encapsulated into a plastic housing and is connected via a cable to the SuniIO USB interface electronics module (2). The USB-interface has two LEDs that indicate USB power (4) and interface activity (5).
The USB Interface is connected to a USB cable using a type "mini-B" USB connector (3). The other end of this cable terminates in a USB plug (6) for connection to a USB port on the host computer.
The System also includes software drivers that control the USB interface module and a Graphical User Interface (GUI) which allows the user access to the data and to control functions of the System.
The SuniIQ is intended to be used with dedicated dental x-ray Imaging software to provide the dental professional user the benefits of "real time" imaging system. The software manufactured by Apteryx (K983111) is such dedicated dental software for dental x-ray imaging.
The System sensors are available in two formats. The #2 size (400-1322) is a larger sensor typical of the European format and the # 1 size (400-1321) is an intermediate size. The sensors consist of a CMOS type integrated circuit, and a high resolution scintillator screen that converts the photons from the X-rays into visible light, which is then acquired by the CMOS imaging integrated circuit. The sensors are encapsulated in a plastic enclosure with a three-foot cable that is connected to the USB interface electronics module.
The USB interface electronics module plugs into a computer USB port via a supplied USB cable. The USB interface electronics module contains the support and control circuitry for the sensor and allows for data communications with the computer. The USB interface electronics module contains all necessary circuits for sensor data acquisition as well as memory for firmware control of the CMOS X-ray sensor and USB. The USB interface electronics module communicates with the computer under control of a specific device driver that is active with the GUL.
The system software functions on three levels: (1) The computer operating system (Microsoft Windows) controls the computer, user interface, and file structure; (2) Primary control of the sensor and bus functions is achieved by proprietary software and is either embedded firmware or in non-user accessible drivers; and (3) A Graphical User Interface (GUI) allows the user to control the x-ray function, control of the sensor data acquisition, and image viewing. manipulation and output. Examples of the GUI include image capture, enhanced viewing
6
features (zoom, pan, colorize, contrast/brightness, comparative analysis, etc.) image organization, and storage.
INDICATIONS FOR USE:
The SuniIQ Digital Radiography system is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
TECHNICAL CHARACTERISTICS:
The SuniIQ Digital Radiography System replaces X-ray film with a reusable electronic sensor that captures the X-ray photons and converts them to an electronic signal which in turn is captured in a computer for viewing, manipulating, storing, and output. The SuniIQ is intended to be used with dedicated dental x-ray imaging software to provide the dental professional user the benefits of "real time" imaging system.
The SuniIO Sensor incorporates a CMOS detector for capture and imaging of x-ray photons. The sensor is encapsulated into a plastic housing and is connected via a cable to the SuniIQ USB interface electronics module.
The USB-interface provides two LEDs to indicate USB power and interface activity. The USB Interface is connected with a provided USB cable to a USB port on the host computer. The USB interface electronics module contains the support and control circuitry for the sensor and allows for data communications with the computer. The USB interface electronics module contains all necessary circuits for sensor data acquisition as well as memory for firmware control of the CMOS X-ray sensor and USB. The USB interface electronics module communicates with the computer under control of a specific device driver that is active with the GUI.
The SuniIQ is available in two sensor versions (designated as #1 & #2 sizes; equivalent to dental film sizes), an attached USB interface electronics module that controls the sensor and interfaces to the computer USB port. The System also includes software drivers that control the USB interface module, a Graphical User Interface (GUI) allows the user access to the data and control functions of the System.
PERFORMANCE STANDARDS:
No applicable performance standards have been issued under 514 of the Food, Drug and Cosmetic Act for a System, X-Ray, Extraoral Source, Digital §872.1800.
SUMMARY OF NONCLINICAL TESTING:
Testing was performed to assure the performance and safety of the SuniIQ System.
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Bench Testing
Bench testing confirmed that the performance of the SuniIQ System meets all functional requirements. This testing included, where relevant, direct comparison to the performance of the predicate SuniRay II System.
| Tested Function | Result |
|---|---|
| Relative error | Pass |
| X-Ray Saturation | Pass |
| Image size | Pass |
| Image orientation | Pass |
| Set up time, USB current and clock pattern | Pass |
| Dose loss and focus to detector distance (FDD) | Pass |
| Saturation Comparison | Pass |
| Printed Circuit Board (PCB) | Pass |
| Software Development Kit (SDK) | Pass |
| Time to ready for exposure state | Pass |
| Test Pattern Images | Pass |
| Dental Phantom Images | Pass |
| Other Operating systems | Pass |
Software V&V
Software verification & validation testing was conducted in accordance with IEC 62304:2006: Medical device software -- Software Life Cycle Processes and with FDA guidances for software development and testing (Guidance for the Content of Premarket Submission for Medical Device Containing Software, FDA-CDRH-CBER, Rockville, MD, 05/2005; Guidance for Off-the-Shelf Software Use in Medical Devices, FDA- CDRH, Rockville, MD, 06/1997; and General Principles of Software Validation; Final Guidance for Industry and FDA Staff, FDA-CDRH, Rockville, MD, 01/2002). All features provided for the SunilQ System have been verified to operate as specified. The software systems were treated as entirely new systems in respect to specification and verification to adjust the documentation and verification requirements to the current state of technology. All test passing criteria for the Software V&V were met. Both software systems were verified entirely to establish a new baseline and regression testing was therefore not indicated.
Biocompatibility
The materials of the device have been evaluated, tested, and determined to meet requirements under ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process, and the FDA draft guidance document Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (April 23, 2013).
8
Disinfection
The recommended cleaning method (intermediate level of disinfection) has been evaluated and confirmed. Testing was performed under Good Laboratory Practices regulations (21CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies).
Electromagnetic Compatibility and Electrical Safety
The System meets the requirements of IEC 60601-1:2005 and ANSI/AAMI ES60601-1:2005 for safety, IEC 60601-1-2:2007 for electromagnetic compatibility.
All features provided for the SunilQ System have been verified to operate as specified. Testing confirms that the SuniIQ System is as safe, as effective, and performs as well as or better than the predicate device.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The SuniIQ Digital Radiography System is substantially equivalent to the listed predicate device with respect to indications for use (intended use) and technical characteristics. The information and data provided in this 510(k) submission identifies no new safety or effectiveness issues.
| ELEMENT | SUNIIQ | SUNRAY II
K070219 |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | "... to collect dental x-ray
photons and convert them
into electronic impulses that
may be stored, viewed and
manipulated for diagnostic
use by dentists." | "... to collect dental x-ray
photons and convert them
into electronic impulses that
may be stored, viewed and
manipulated for diagnostic
use by dentists." |
| Design Features | | |
| Indirect converting CMOS
detector | ✓ | ✓ |
| USB power supply | ✓ | ✓ |
| USB data interface | ✓ | ✓ |
| Active imaging area:
Size 1: 31.1 x 20.2mm²
Size 2. 35.2 x 26.2 mm² | ✓ | ✓ |
| 33 µm pixel pitch | ✓ | ✓ |
| 4096:1 dynamic range | ✓ | ✓ |
| Materials (potential patient
contact)
Ultem HU1010 sensor enclosure
Polyurethane cable jacket | ✓ | ✓ |
| Detector to USB A cable length | ✓ | ✓ |
9
| ELEMENT | SUNIIQ | SUNRAY II
K070219 |
|--------------------------------------------------------------------------------------------------------------------------------------------|--------|----------------------|
| = 70cm + length of USB cable
Detector to USB B cable length
= 70cm + length of USB cable | ✓ | ✓ |
| Principles of Operation | | |
| • Indirect converting CMOS
(complementary metal-oxide
semiconductor) detector | ✓ | ✓ |
| • Cesium-Iodide (CsI)
scintillator: emits visible light
in proportion to the x-ray
energy received | ✓ | ✓ |
| • Fiber optic plate; coupled to
scintillator, transmits light to
CMOS while blocking x-rays | ✓ | ✓ |
| • CMOS captures visible light
into a matrix of photodiodes
and other transistors, each
forming a pixel of the
resulting image. | ✓ | ✓ |
| • Photodiodes are n-well over
p-type substrate | ✓ | ✓ |
| • Each pixel consists of 3
NMOS transistors and a
photodiode. | ✓ | ✓ |
| • Pixel voltage resetting value | 3.5V | 2.9V |
The identified technological differences between the subject and predicate devices were assessed through bench performance testing data and software V&V testing to demonstrate that they are substantially equivalent.