(55 days)
Acquisition of intraoral X-Ray image of the human dental arch. In particular:
• The STARX-1/ STARX PRO-1 sensors (active area 20 x 30 mm) allow to acquire the majority of intraoral images both vertically and horizontally.
• The STARX-2/ STARX PRO-2 sensors (active area 26 x 34 mm) allow to acquire horizontal bitewing images.
The StarX-1, StarX-2, StarX PRO-1 and the StarX PRO-2 are digital intraoral sensors based on CMOS technology for intraoral X-Ray image acquisition of the human dental arch. The sensors are available in two sizes; in particular:
• StarX-1 / StarX PRO-1 sensors: active area 20 x 30 mm
• StarX-2 / StarX PRO-2 sensors: active area 26 x 34 mm
The differences between the sensors are the sizes and the different kind of scintillator (Cesium lodide - Csl and Gadolinium Oxysulfide - GOS).
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 are directly connected to the acquisition PC through the USB connection. Up to three sensors can be connected to one PC at time.
The type of X-ray systems that integrate with the sensors are wall-mounted Xray intraoral generators (both AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and 100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/kV to be selected, which will control the exposure time.
The sensor is supplied with an acquisition (TWAIN) module to acquire images from the sensor via the USB. The user can further process these images via a patient management software to process, filter and modify images using a software such as the Oris Win DG software which is not part of this submission.
The device cannot act as an x-ray generator controller. All control of x-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the x-ray generator. The subject device does not control the generator, it is a receiver only.
Before FONA sells this device, the team discuss the hardware and software requirements of the user to make sure that their systems are compatible with the FONA sensors.
FONA provides technical support for this device to ensure proper operation and to answer any questions regarding the functioning of the device. Contact details are provided to all end users and in the user manual.
This document describes the regulatory submission for the StarX-1, StarX-2, StarX PRO-1, and StarX PRO-2 intraoral digital X-ray sensors. The submission aims to establish substantial equivalence to a predicate device (Quick Ray HD, K151926).
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Intended Use | Acquisition of intraoral X-Ray image of the human dental arch for diagnosis of dental diseases. | Acquisition of intraoral X-Ray image of the human dental arch. |
| Sensor Technology | CMOS chip + optical fiber plate + CSi | STARX PRO: CMOS + Optical fiber plate + CSi STARX: CMOS + Optical Fiber plate + GOS |
| Matrix Dimensions (Size 1) | Active area: 600mm² | STARX-1 and STARX PRO-1: 600mm² |
| Matrix Dimensions (Size 2) | Active area: 884mm² | STARX-2 and STARX PRO-2: 884mm² |
| Matrix Dimensions (Pixels, Size 1) | 1000 lines X 1500 columns | 1000 x 1500 (STARX-1 and STARX PRO-1) |
| Matrix Dimensions (Pixels, Size 2) | 1300 X 1700 | 1300 x 1700 (STARX-2 and STARX PRO-2) |
| Resolution | Real ≥ 20lp/mm (for CSi-based) | STARX 12lp/mm (GOS)STARX PRO 20lp/mm (CSi) |
| Pixel Size | 20x20 µm | 20x20 µm |
| Grey Levels | 14 bits | 14 bits |
| Lifespan (CMOS) | Min. 100,000 cycles | Min. 125,000 cycles |
| Operating Temperature | 0°C to 35°C | 0°C to 35°C |
| Sensor Input Voltage/Current | 5V (via USB connection); 0.15A Max | 5V (via USB connection); 0.15A Max |
| Clinical Adequacy | Clinically acceptable image quality for diagnostic purposes. | Professional evaluation of imaging samples found to be of good quality, high resolution, clinically acceptable, and substantially equivalent to the predicate device. |
| Electrical Safety | Compliance with IEC 60601-1. | Compliance with IEC 60601-1. |
| EMC | Compliance with IEC 60601-1-2. | Compliance with IEC 60601-1-2. |
| Usability | Compliance with IEC 60601-1-6 & IEC 62366-1. | Compliance with IEC 60601-1-6 & IEC 62366-1. |
| Performance (Imaging) | Compliance with IEC 61223-3-4 and IEC 62220-1 (DQE). | Compliance with IEC 61223-3-4 and IEC 62220-1. |
| IP Code | Compliance with IEC 60529. | Compliance with IEC 60529. |
Note on Acceptance Criteria: The document primarily relies on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implied by the performance characteristics and regulatory compliance of the predicate device. The applicant aims to show that their device performs equivalently or better in relevant aspects.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Sample clinical images from the FONA device were evaluated." However, it does not specify the sample size for this clinical evaluation.
The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is FONA S.r.l. from Italy. The study appears to be a retrospective evaluation of images.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document states: "Professional evaluation of imaging samples were found to be of good quality, high resolution, clinically acceptable and substantially equivalent to the predicate device."
- Number of experts: Not specified.
- Qualifications of experts: Only referred to as "Professional." No specific qualifications (e.g., "radiologist with 10 years of experience") are provided.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the evaluation of clinical images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided text. The evaluation method focused on the quality and acceptability of images from the new device rather than comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The device itself (StarX intraoral digital X-ray sensor) is an image acquisition component, not an AI algorithm for image analysis. Therefore, a "standalone algorithm performance" study as typically understood for AI-driven diagnostic tools would not be applicable in this context. The performance evaluated here relates to the imaging capabilities (resolution, grey levels, DQE, etc.) and clinical adequacy of the acquired images.
7. The Type of Ground Truth Used
The ground truth for the clinical evaluation was based on expert consensus regarding the "good quality, high resolution, clinically acceptable" nature of the images.
8. The Sample Size for the Training Set
The document does not mention any training set or associated sample size. This device is an image acquisition sensor, not an AI or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned (since this is an image acquisition device, not an AI model), this question is not applicable.
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August 30, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
FONA S.r.1. % Krupa Srivastava RA Consultant Via G. Galilei 11 Assago, Milan 20057 ITALY
Re: K212103
Trade/Device Name: StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: June 30, 2021 Received: July 6, 2021
Dear Krupa Srivastava:
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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) K212103
Device Name StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2
Indications for Use (Describe)
Acquisition of intraoral X-Ray image of the human dental arch. In particular:
• The STARX-1/ STARX PRO-1 sensors (active area 20 x 30 mm) allow to acquire the majority of intraoral images both vertically and horizontally.
· The STARX-2/ STARX PRO-2 sensors (active area 26 x 34 mm) allow to acquire horizontal bitewing images.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for FONA. The word "FONA" is written in large, gray, sans-serif letters. Above the word is a yellow arc. Below the word "FONA" are the words "CLOSER TO YOU" in smaller, gray, sans-serif letters.
K212103
510(k) SUMMARY
Date Prepared:
June 30, 2021
Submitters Information Name
Address
Contact Person
Contact Telephone
FONA s.r.l. Via G.Galilei 11 20057 Assago (MI), Italy Luigi Germanò +39 0245712171
Device Information
StarX-1, StarX-2, StarX PRO-1 and StarX Device/ Trade Name PRO-2 Intraoral Digital X-Ray Sensor Common Name Classification Name Extraoral source x-ray system 21 CFR 872.1800 Classification Regulation MUH Product code
Predicate Devices:
The following legally marketed predicate device has been chosen for the determination of substantial equivalence:
| Trade Name | Quick Ray HD |
|---|---|
| 510(k) Number | K151926 |
| Classification Name | Extraoral source x-ray system |
| Classification Regulation | 21 CFR 872.1800 |
| Product code | MUH |
Indications for use
Acquisition of intraoral X-Ray image of the human dental arch. In particular:
- The STARX-1/ STARX PRO-1 sensors (active area 20 x 30 mm) allow to ● acquire the majority of intraoral images both vertically and horizontally.
- The STARX-2/ STARX PRO-2 sensors (active area 26 x 34 mm) allow to ● acquire horizontal bitewing images.
Traditional 510(k)- StarX & StarX PRC
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Image /page/4/Picture/0 description: The image shows the logo for FONA. The word "FONA" is written in large, bold, gray letters. Above the word "FONA" is a curved yellow line. Below the word "FONA" are the words "CLOSER TO YOU" in smaller, gray letters.
Device Description:
The StarX-1, StarX-2, StarX PRO-1 and the StarX PRO-2 are digital intraoral sensors based on CMOS technology for intraoral X-Ray image acquisition of the human dental arch. The sensors are available in two sizes; in particular:
- . StarX-1 / StarX PRO-1 sensors: active area 20 x 30 mm
- . StarX-2 / StarX PRO-2 sensors: active area 26 x 34 mm
The differences between the sensors are the sizes and the different kind of scintillator (Cesium lodide - Csl and Gadolinium Oxysulfide - GOS).
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 are directly connected to the acquisition PC through the USB connection. Up to three sensors can be connected to one PC at time.
The type of X-ray systems that integrate with the sensors are wall-mounted Xray intraoral generators (both AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and 100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/kV to be selected, which will control the exposure time.
The sensor is supplied with an acquisition (TWAIN) module to acquire images from the sensor via the USB. The user can further process these images via a patient management software to process, filter and modify images using a software such as the Oris Win DG software which is not part of this submission.
The device cannot act as an x-ray generator controller. All control of x-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the x-ray generator. The subject device does not control the generator, it is a receiver only.
Before FONA sells this device, the team discuss the hardware and software requirements of the user to make sure that their systems are compatible with the FONA sensors.
FONA provides technical support for this device to ensure proper operation and to answer any questions regarding the functioning of the device. Contact details are provided to all end users and in the user manual.
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Image /page/5/Picture/0 description: The image shows the logo for FONA. The word "FONA" is written in large, gray, sans-serif letters. Below the word "FONA" is the phrase "CLOSER TO YOU" in smaller, gray, sans-serif letters. Above the word "FONA" is a yellow swoosh.
Substantial Equivalence:
The subject device and predicate device are identical in firmware/hardware and supplied by the same company, Hamamatsu. The firmware in the FONA devices has already been cleared in the Predicate Device.
The sensor technology and principle of operation remain the same. The FONA StarX-1 and StarX-2 utilise the GOS scintillator which work on similar principles as the CSi scintillator found in the StarX PRO and the predicate devices. Clinical as well as the Non-Clinical testing performed on these FONA devices do not raise any concern of safety or effectiveness as compared to the predicate device.
The predicate device comes with Xray Vision (OTS package from Apteryx, USA) which performs image acquisition, archiving, image enhancements, electronic transmission and diagnostic review system.
The FONA sensor is supplied only with an acquisition (TWAIN) module to acquire images from the sensor via the USB. The user can further process these images via a patient management software to process, filter and modify images using a software such as the Oris Win DG software which is not part of this submission.
A comparison of the FONA sensors to the predicate device is tabulated below:
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Image /page/6/Picture/0 description: The image shows the logo for FONA, a company that uses the tagline "Closer to You". The word "FONA" is written in large, bold, gray letters. Above the word "FONA" is a yellow swoosh. Below the word "FONA" is the tagline "Closer to You", which is written in smaller, gray letters.
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | STARX-1, STARX-2, STARX PRO-1 and STARX PRO-2 | Quick Ray HD |
| Manufacturer Name | FONA S.r.l | Denterprise International |
| Device ClassificationRegulation | 21 CFR 872.1800 | 21 CFR 872.1800 |
| Common Name | Intraoral Digital X-Ray Sensor | Intraoral Digital X-Ray Sensor |
| Classification Name | Extraoral Source X-Ray System | Extraoral Source X-Ray System |
| Product Code(s) | MUH | MUH |
| Regulatory Class | 2 | 2 |
| 510(k) | Not yet assigned | K151926 |
| Intended Use | The acquisition of intraoral X-Ray image of thehuman dental arch. In particular:• The size 1 sensor allows to acquire the majorityof intraoral images both vertically andhorizontally.• The size 2 sensor allows to acquire horizontalbitewing images. | Radiographic examination to assistwith diagnosis of diseases of the teeth,jaw, and oral structure.The QuickRay HD dental sensor isintended to replace film and to capture anintraoral x-ray image, when exposed to X-rays, for dental diagnostic purposes. |
| Software | TWAIN (Standard) Module which is a communicationprotocol used for image acquisition only. It works withany compatible patient management system. | Xray Vision (OTS package from Apteryx,USA) K983111- performs imageacquisition, archiving, imageenhancements, electronic transmissionand diagnostic review system. |
| Principles ofOperation | X-ray (radiation) => scintillator (convert to light) =>fiber optic (filtering) => CMOS (convert to digital) =>electronics => PC (capture & display image) | X-ray (radiation) => scintillator (convert tolight) => fiber optic (filtering) => CMOS(convert to digital) => electronics => PC(capture & display image) |
| Subject Device | Predicate Device | |
| Device Name | STARX-1, STARX-2, STARX PRO-1 and STARXPRO-2 | Quick Ray HD |
| Software-Firmware | Firmware combined on sensor electronic board | Firmware combined on sensor electronicboard |
| Sensor technology | STARX PRO: CMOS + Optical fiber plate + CSiSTARX: CMOS+ Optical Fiber plate + GOS | CMOS chip + optical fiber plate + CSi |
| Matrix dimensions(mm²) | (Size 1) STARX-1 and STARX PRO-1: 600mm²(Size 2) STARX-2 and STARX PRO-2: 884mm² | Active area: 600mm² (Size 1)884mm² (Size 2) |
| Matrix dimensions(pixels) | 1000 x 1500 (STARX-1 and STARX PRO-1)1300 x 1700 (STARX-2 and STARX PRO-2) | 1000 lines X 1500 columns (Size 1)1300 X 1700 (Size 2). |
| Resolution | STARX 12lp/mmSTARX PRO 20lp/mm | Real ≥ 20lp/mm |
| Pixel Size | 20x20 µm | 20x20 µm |
| Sterilization | Not sterile. Disinfect and use | Not sterile. Disinfect and use |
| Shelf life/ LifespanCMOS | Min. 125,000 cycles | Min. 100,000 cycles |
| Grey Levels | 14 bits | 14 bits |
| Sensor Board | All control electronics directly integrated on CMOSsensor chip | All control electronics directly integrated onCMOS sensor chip |
| Sensor shell | Enclosure for sensor is ABS and the flammability isHB of UL-94 (UL File No.49895) | Specific shape design; material is ABS andthe flammability is HB if YK- 94 (UL FileNo. 49895) |
| Cable material anddesign | Cable consists of PVC, ETFE, Copper, plugconnector and sensor connector, diameter ø3.7 ±0.3and cable length of 2 meters | Cable consists of PVC, ETFE, copper, plugconnector and sensor connector, diameterø3.7 ±0.3 and cable length 2 meters. |
| Connection toimaging practice PC | USB 2.0 High-Speed | USB 2.0 High-Speed |
| Subject Device | Predicate Device | |
| Device Name | STARX-1, STARX-2, STARX PRO-1 and STARXPRO- 2 | Quick Ray HD |
| Operatingtemperature | 0°C to 35°C | 0°C to 35°C |
| Sensor input voltageand current | 5V (via USB connection); 0.15A Max | 5V (via USB connection); 0.15A Max |
| PerformanceStandards | IEC 60601-1 (Electrical)IEC 60601-1-2 (EMC)IEC 60601-1-6 & IEC 62366-1 (Usability)IEC 61223-3-4 (performance)IEC 62220-1 (DQE-performance)IEC 60529 (IP Code) | IEC 60601-1 (Electrical);IEC 60601-1-2 (EMC)62220-1 (Performance)60529 (IP Code) |
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Image /page/7/Picture/0 description: The image shows the logo for FONA, a company that provides dental imaging solutions. The logo consists of the word "FONA" in large, gray, sans-serif font, with the tagline "CLOSER TO YOU" in smaller, gray, sans-serif font underneath. A yellow arc is positioned above the word "FONA", adding a visual element to the logo.
Traditional 510(k)- StarX & StarX PRO FONA S.r.l
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ll FONA S.r.l.– Socio Unico - Sede legale, 11 - 2005 Assago (M) Mala - Capitale Sociale Sociale Sociale Sociale Social .V.A.: 1283700159 - Isozione Registo Inpose di Milano REA:1606385 - Telefono: +39 02 45712171 - Fax: +39 02 45703385 - E-mail: info@fonaitaly.com - Web: www.fonadental.it
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Image /page/8/Picture/0 description: The image shows the logo for FONA, a company with the tagline "CLOSER TO YOU". The word "FONA" is written in large, bold, gray letters. Above the word "FONA" is a yellow curved line. Below the word "FONA" is the tagline "CLOSER TO YOU" in smaller, gray letters.
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ll FONA S.r.l.– Socio Unico - Sede legale, 11 - 2005 Assago (M) Mala - Capitale Sociale Sociale Sociale Sociale Social .V.A.: 1283700159 - Isozione Registo Inpose di Milano REA:1606385 - Telefono: +39 02 45712171 - Fax: +39 02 45703385 - E-mail: info@fonaitaly.com - Web: www.fonadental.it
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Image /page/9/Picture/0 description: The image shows the logo for FONA. The word "FONA" is written in large, gray, sans-serif letters. Above the word is a yellow arc. Below the word "FONA" is the phrase "CLOSER TO YOU" in smaller, gray, sans-serif letters.
The comparison table reveals there are no new technical issues of safety or effectiveness raised by the substitution of the scintillator. Professional evaluation of imaging samples were found to be of good quality, high resolution, clinically acceptable and substantially equivalent to the predicate device.
Summary of Non Clinical Testing: IEC standards have been employed for Electrical Safety, Electromagnetic Compatibility, performance and usability. The panel power supply is UL Listed. The CMOS area image sensor manufacturer conducted performance testing according to the FDA quidance document for solid state digital X-ray panels. Risk Analysis and System operation verification tests were conducted in accordance with FDA guidance documents. Labelling was developed to comply with the FDA solid state panel guidance document.
Summary of Clinical Testing: Sample clinical images from the FONA device were evaluated as per the FDA guidance document for solid state digital X-ray panels and found to be clinically adequate.
Conclusion: After analysing non-clinical data, electrical safety as well as clinical evaluation, it can be concluded that the FONA devices are as safe and effective as the predicate device, has few technological differences, and has no new intended use, thus rendering it substantially equivalent to the predicate device.
§ 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.