QuickRay HD is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.

Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure.

The QuickRay HD dental sensor is intended to replace film and to capture an intraoral x-ray image, when exposed to X-rays, for dental diagnostic purposes.

Device Description

The subject QuickRay HD are intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Mangement Software package.

The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².

QuickRay HD, Size 1 is also known as factory code S11684-12; QuickRay HD, Size 2 is also known as factory code S116845-12.

The type of x-ray systems that integrate with the QuickRay HD sensor are wall-mounted xray 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, all will control the exposure time.

This device and software 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.

The Xray Vision software by Apteryx is a Windows based image management database/software primarily used by dentists to acquire, enhance, store, communicate, print, recall and display digital images.

AI/ML Overview

Here's an analysis of the provided text to extract information related to acceptance criteria and the study proving the device meets them. It's important to note that this document is a 510(k) summary for a premarket notification, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial. As such, some of the requested information (like detailed MRMC studies or large-scale multi-expert ground truthing) may not be explicitly present or required for this type of submission.

The device in question is the QuickRay HD Intraoral Sensor.

Acceptance Criteria and Device Performance Study for QuickRay HD Intraoral Sensor

Context: The QuickRay HD Intraoral Sensor is an intraoral digital X-ray system intended for radiographic examination to assist in diagnosing diseases of the teeth, jaw, and oral structures. The 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device (Opteo, K133271) and an identical device cleared later (EDLENi Intra-oral Sensor, K150823), rather than extensive new clinical performance studies, which is typical for Class II dental imaging devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific 510(k) submission, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device, meaning the QuickRay HD must perform comparably or better than the predicate, especially in terms of image quality and safety. The performance is assessed through bench testing and by comparing technological characteristics.

Criterion Category (Implied Acceptance Basis)	Specific Criterion / Metric	QuickRay HD Performance (Subject Device)	Predicate Opteo Performance (for comparison)	Notes / Supporting Information
Intended Use	Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structures.	QuickRay HD used for radiographic examination by dental professional to assist in diagnosing diseases of the teeth, jaw and oral structures.	Same.	QuickRay HD is intended to replace film and capture intraoral x-ray images for dental diagnostic purposes.
Technological Characteristics	Sensor Technology	CMOS chip + optical fiber plate + CSi scintillator	CMOS chip + optical fiber plate + CSi scintillator	Identical.
Image Resolution	Real Resolution	≥ 20 lp/mm	≥ 20 lp/mm	Meets or exceeds the predicate.
Pixel Size		20 x 20 μm	20 x 20 μm	Identical.
Matrix Dimensions (Active Area)	Size 1	600mm²	600mm²	Identical.
	Size 2	884mm²	900mm²	"None" (difference not considered significant for equivalence).
Matrix Dimensions (Pixels)	Size 1	1000 lines X 1500 columns	1000 lines X 1500 columns	Identical.
	Size 2	1300 X 1700	1300 X 1700	Identical.
Grey Levels		14 bits	14 bits	Identical.
Lifespan (CMOS)	Minimum cycles	Min. 100,000 cycles	Min. 100,000 cycles	Identical.
Electrical Safety	Conformance to IEC 60601-1	Conforms	Conforms	Confirmed by testing data.
EMC	Conformance to IEC 60601-1-2	Conforms	Conforms	Confirmed by testing data.
Bench Testing (Performance)	Detective Quantum Efficiency (DQE)	DQE plot provided (Figure/3)	(Not directly compared in table, but implied to be comparable to predicate performance in similar technologies)	Conforms to IEC 62220-1. Calculation includes MTF and NMPS, with plots provided.
	Modulation Transfer Function (MTF)	MTF plot provided (Figure/0)	(Not directly compared in table)	Conforms to IEC 62220-1.
	Noise Power Spectrum (NNPS)	NNPS plot provided (Figure/1)	(Not directly compared in table)	Conforms to IEC 62220-1.
Biocompatibility	Patient contact	No direct or indirect patient-contacting components. Single-use protective barrier used.	Same.	Not warranted for separate testing.
Clinical Relevance	Diagnostic relevance and reliability	Clinical images examined by Dr. Parham and found to be diagnostically relevant and reliable.	Implied equivalent.	Limited clinical assessment, primarily by one practitioner.

Note: The document explicitly states that the EDLENi Intra-oral Sensor (K150823) is identical to the QuickRay HD, providing further support for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a quantitative "test set sample size" in terms of number of patients or images for a comparative clinical study. The performance assessment is primarily based on:
- Bench Testing: Conformance to standards (IEC 62220-1 for performance, IEC 60601-1/1-2 for electrical/EMC, IEC 60529 for IP Code). These involve standardized phantom or controlled laboratory tests rather than patient images as a "test set."
- Clinical Image Examination: "Clinical images were examined" by Dr. Parham. The number of images or cases examined is not specified.
Data Provenance: The document does not explicitly state the country of origin for the "clinical images" examined by Dr. Parham, but given the location of Dr. Parham (Ormond Beach, FL), it implies the data is from the United States. The study type appears to be retrospective in nature ("clinical images were examined"), rather than a prospectively designed clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Only one expert is explicitly mentioned: "Dr. Parham".
Qualifications of Experts: Dr. Parham is described as "a qualified practitioner in Ormond Beach, FL." No further specific qualifications (e.g., years of experience, specific board certifications like radiologist) are provided in this summary, other than the implication of being a dental professional.

4. Adjudication Method for the Test Set

Adjudication Method: None explicitly stated or implied. The assessment was done by a single "qualified practitioner."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission relies on bench testing and a single expert's review of clinical images to demonstrate substantial equivalence, not a direct human reader performance comparison with and without AI assistance. Therefore, no effect size for human readers improving with AI assistance is provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: The QuickRay HD is an imaging sensor, not an AI algorithm. Its "performance" is inherently tied to its ability to capture images suitable for human diagnosis. Therefore, the concept of a "standalone (algorithm only)" performance study doesn't directly apply here in the typical AI sense. The bench tests (DQE, MTF, NNPS) represent the inherent technical performance of the device itself (analogous to "standalone" in a hardware context) before image interpretation by a human.

7. The Type of Ground Truth Used

Type of Ground Truth: For the "clinical images," the ground truth was expert consensus / expert opinion, specifically from "Dr. Parham," who found them "diagnostically relevant and reliable." For the technical performance aspects (resolution, DQE, etc.), the ground truth was based on physical measurements and conformance to established international standards (e.g., IEC 62220-1).

8. The Sample Size for the Training Set

Training Set Sample Size: The QuickRay HD is a hardware device (intraoral sensor) with associated firmware and image management software. It is not an AI/ML algorithm that is "trained" on a dataset in the typical sense. Therefore, there is no stated training set sample size. The electronics and firmware are reported to be from Hamamatsu and the software from Apteryx, and these components have presumably undergone their own development and testing processes, but no specific training data for the sensor itself for a machine learning purpose is relevant or mentioned.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: As the device is not an AI/ML algorithm requiring a training set, the concept of "ground truth for the training set" is not applicable in this context. The "truth" for this device lies in its physical and electrical engineering specifications and its ability to produce images that meet diagnostic quality standards established by experts and industry benchmarks.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are connected and form a single, flowing shape. The graphic is surrounded by a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 14, 2015

Denterprise International, Inc. % Mr. Claude Berthoin Regulatory Executive, Owner 100 East Granada Blvd., Suite 219 ORMOND BEACH FL 32176

Re: K151926

Trade/Device Name: OuickRav HD Intraoral Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: November 24, 2015 Received: November 30, 2015

Dear Mr. Berthoin:

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.

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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 Oals

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)

K151926

Device Name QuickRay HD Intraoral Sensor

Indications for Use (Describe)

QuickRay HD is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.

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/0 description: The image shows the logo for Denterprise International, Inc. The logo features a stylized blue tooth graphic to the left of the word "DENTERPRISE" in gray block letters. Below "DENTERPRISE" is the text "INTERNATIONAL, INC" in smaller gray letters.

100 E. Granada Blvd. Suite 219 Ormond Beach, FL 32176 Ph: 386-672-0450 800-323-2690

510 (k) Summary

Submitter

Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176

Phone: 386-672-045 Fax: 855-235-7902 Contact Person: Claude Berthoin Date Prepared: July 10, 2015

Device Classification

Trade Name: QuickRay HD Common Name: Intraoral Digital X-Ray Sensor Regulation Number: 21 CFR 872.1800 Classification Name: Extraoral Source X-Ray System Product Code: MUH Submission Type: 510(k) Regulatory Class: 2 Medical Specialty: Dental

Predicate Device

The following predicate is a legally marketed, post-amendment device:

510(k) Number: K133271 Clearance Date: April 28, 2014 Actual Trade Name: Opteo Regulation & PC: 872.1800; MUH

Reference Device: 510(k) Number: K150823 August 265, 2015 Clearance Date:

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Actual Trade Name: EDLENi Intra-oral Sensor Regulation & PC:

K150823 was in review when the subject device was submitted in July. This device is identical to the subject device. The K150823 would have been used as the predicate had it been available.

Device Description

The subject QuickRay HD are intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Mangement Software package.

The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².

QuickRay HD, Size 1 is also known as factory code S11684-12; QuickRay HD, Size 2 is also known as factory code S116845-12.

Before Denterprise sells this device, our technicians discuss the hardware and software that the dentist has, to make sure that their systems are compatible with the QuickRay HD sensor. Denterprise offers technical support for this device to ensure proper operation and to answer any questions regarding the function of the device. A means to contact Denterprise is provided to all end users and in our user manual.

X-ray Vision, software by Apteryx (K983111) cleared on November 16. 1998, is supported on Windows SP. Vista. 7. 8. 8.1 and 10. Absolute minimum requirements for PC hardware for the sensor and software combination would be a Pentium 4 or better processor. At least 1 GB of RAM, 200MB of hard drive space for the software, plus additional space for the user database (recommended 40GB minimum), a USB 2.0 or 3.0 and a 100MB wired Ethernet connection is needed if networked.

The Xray Vision software by Apteryx is a Windows based image management database/software primarily used by dentists to acquire, enhance, store, communicate, print, recall and display digital images.

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The firmware in the QuickRay HD has already been cleared. The exact same device as the subject is EDLENi Intra-Oral Sensor, K150823. We could not use this device as our predicate because it was in review and cleared August 26, 2015. Our subject device was submitted for review in July 10, 2015. The subject device is identical in firmware/hardware from Hamamatsu, and the software is identical from Aptervx. Hamamatsu is the main subcontractor of this device for Denterprise International, Inc.

The EDLENi device also has 2 sizes like our subject device. The subject device and the EDLENi device are identical in all aspects of the device. They will have different names only for marketing purposes. The subject and predicate device are similar and the differences do not change the safety and effectiveness of the subject device.

The latest publication of CR Clinicians the November newsletter reports that 70% of all the practices use dental sensors and only 16% use film. This newsletter may be reviewed in section 21 Other.

Indications for Use

QuickRay HD is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.

Intended Use

Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure.

The QuickRay HD dental sensor is intended to replace film and to capture an intraoral x-ray image, when exposed to X-rays, for dental diagnostic purposes.

Comparison of Technological Characteristics with Predicate

The subject QuickRay HD and predicate Opteo are similar dental devices.

Both are comprised of the following two components...

. Intraoral Detector System... The subject device and predicate device includes an intraoral detector, flexible cord, and direct USB 2.0 plug, as described in subject OuickRay HD and predicate Opteo marketing literature in this petition
Imaging Software... The subject is using a third party software called Xray Vision . which is manufactured by Apteryx in Akron, Ohio (K983111) cleared November 16, 1998. The predicate uses Owandy proprietary software called QuickView.

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Comparison Table

	QuickRay HD(Subject)	Opteo(Predicate)	Differences
510(k)	Not assigned yet	K133271 (Cleared April28, 2014)	NA
Applicant/Assembler/Repackager/Relabeler	Denterprise International(Ormond Beach, FL)	Owandy (Croissy-Beauvourg, France	NA
Manufacturer-Imaging SWComponent	Apteryx (Akron, OH)	Owandy, France	Similar
Classification & Product Code	872.1800; MUH	872.1800; MUH	None
Common name	Intraoral Digital X-RaySensor	Intraoral Digital X-RaySensor	None
Intended use	Radiographicexamination to assistwith diagnosis ofdiseases of the teeth,jaw, and oral structure.	Radiographicexamination to assistwith diagnosis ofdiseases of the teeth,jaw, and oral structure.	None
Principles of operation	X-ray (radiation) =>scintillator (convert tolight) => 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)	None
Software-Firmware	Firmware combined onsensor electronic board	Firmware combined onsensor electronic board	None
Software-Image Management	Xray Vision (OTS packagefrom Apteryx, USA)	Owandy proprietary(QuickView) third party	None
Sensor technology	QuickRay HD: CMOS chip+ optical fiber plate + CSiscintillator	CMOS chip + optical fiberplate + CSi scintillator	None
Matrix dimensions (mm2)	Active area: 600mm²(Size 1) 884mm² (Size 2)	Active area: 600mm²(Size 1); 900mm² (Size 2)	None
Matrix dimensions (pixels)	1000 lines X 1500columns (Size 1); 1300 X1700 (Size 2).	1000 lines X 1500columns (Size 1); 1300 X1700 (Size 2).	None
Lifespan CMOS	Min. 100,000 cycles	Min. 100,000 cycles	None
Resolution	Real ≥ 20pl/mm	Real ≥ 20pl/mm	None
Pixel size	20 X 20μm	20 X 20μm	None
Grey levels	14 bits	14 bits	None
Sensor board	All control electronicsdirectly integrated onCMOS sensor chip	All control electronicsdirectly integrated onCMOS sensor chip	None
Sensor shell	Specific shape design;material is ABS and theflammability is HB if YK-94 (UL File No. 49895)	Specific shape design;material is thermoplasticpolyamide (GrilamidLV3H Black)	None
Cable material and design	Cable consists of PVC,ETFE, copper, plugconnector and sensorconnector, diameter ф3.7±0.3 and cable length 2meters.	4 conductor cable withpolyurethane sheath,external global diameterof 3.5mm	None
Connection to imaging practicePC	USB 2.0 High-Speed	USB 2.0 High-Speed	None
Operating temperature	0°C to 35°C	10°C to 40°C	None
Sensor input voltage and current	5V (via USB connection);0.15A Max	5V (via USB connection);0.15A Max	None
Standards of conformity	IEC 60601-1 (Electrical);IEC 60601-1-2 (EMC)62220-1 (Performance)60529 (IP Code)	IEC 60601-1 (Electrical);IEC 60601-1-2 (EMC)	None

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Input Calculation software*1 Output

$$DQE = \frac{MTF^2}{\Phi \cdot NMPS}$$

Image /page/7/Figure/3 description: The figure shows a plot of DQE [%] versus Spatial Frequency [cycles/mm]. The x-axis ranges from 0 to 25, while the y-axis ranges from 0.0 to 1.0. The plot shows a curve that starts at approximately 0.45 DQE at 0 cycles/mm and decreases to nearly 0 DQE at 25 cycles/mm.

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Image /page/8/Figure/0 description: This image is a plot of the Modulation Transfer Function (MTF) versus spatial frequency. The x-axis represents spatial frequency in cycles per millimeter, ranging from 0 to 25. The y-axis represents the MTF, ranging from 0 to 1. The plot shows a curve that starts at MTF=1 at a spatial frequency of 0 and gradually decreases as the spatial frequency increases, indicating a reduction in image contrast with increasing spatial frequency.

Image /page/8/Figure/1 description: The figure is a plot of NNPS [mm^2] vs Spatial Frequency [cycles/mm]. The y-axis is on a log scale from 1.E-08 to 1.E-04. The x-axis is on a linear scale from 0 to 30. The plot shows a curve that decreases from approximately 1.E-06 at x=0 to approximately 1.E-07 at x=25.

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Performance Data

Clinical images were examined by Dr. Parham, a qualified practitioner in Ormond Beach, FL and found to be diagnostically relevant and reliable.

Biocompatibility

Biocompatible testing for the subject is not warranted because there are no direct or indirect patient-contacting components in the subject device. It is covered with a single-use protective barrier prior to each use just like the Opteo predicate.

Electrical Safety and EMC

EMC and electrical safety testing data reports for the subject device are provided in this petition.

The QuickRay HD sensor conforms to electrical and safety standard IEC 60601-1 ● (Medical Electrical Equipment, Part I: General requirements for basic safety and essential performance).
The QuickRay HD sensor conforms to electrical and safety standard IEC 60601-1-2 (Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential 3271performance - collateral standard: Electromagnetic compatibility).

Software Verification and Validation Testing

QuickRay HD electronics contains firmware along with a driver both provided by Hamamatsu. Additionally, QuickRay HD uses image management software provided by Apteryx Company; therefore, only firmware and driver documentation for the subject device are included in this petition.

Bench Testing

Bench tests were performed in conformance with IEC 6220-1 (Medical Electrical Equipment - Characteristics of Digital X-ray Imaging Devices-Part 1: Determination of the Detective Quantum Efficiency and IEC 60529 (Degrees of Protection Provided by Enclosures-IP Codes).

Conclusions

The subject and the predicate device have the same intended use and the same technological features. QuickRay HD and Opteo share the same principles of operation, sensor technology,

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use the same USB connection to PC and use similar imaging firmware. The conclusion is that the subject device is as safe and effective as the predicate.

Since the subject device went in for review an identical device has been cleared. The EDLENi with K150823 was cleared August 26, 2015. This device is identical to the subject device. The sensors will only have different brand names for marketing purposes. Again, K150823 and K151926 are identical. Therefore, QuickRay HD warrants a finding of substantial equivalence to both the legally marketed original Opteo and the newly cleared EDLENi sensor and thus clearance for premarket activities in the United States.

Regulation Number and Section

§ 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.