The Handheld Dental X-ray System, model XVbeam2000, is indicated for use only by a trained and qualified dentist or dental technician as an extraoral X-ray source to produce diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

Device Description

The subject device Handheld Dental X-ray System, model XVbeam2000, is a battery-operated, portable extraoral X-ray source system that is designed to generate X-rays to produce diagnostic quality intraoral X-ray images utilizing intraoral image receptors. The device can be used with three receptor types: film, digital intraoral X-ray sensors, and phosphor plates. The subject device is designed for use in a dental office or similar environments (hospital ward etc.) where appropriate safeguards are implemented. The subject device XVbeam2000 is an X-ray device with a DC generator. The handheld device features a main body (X-ray tube head), rechargeable battery (handset), charger, and charger AC/DC power supply. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient. The power is supplied by a rechargeable Lithium-Ion battery core pack built into a handset. This facilitates portability of the device.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (XVbeam2000 Handheld Dental X-ray System). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria through clinical trials or performance studies that would typically generate the requested information.

Therefore, the requested information about acceptance criteria for device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly available in the provided document. The document focuses on demonstrating substantial equivalence through non-clinical performance testing and compliance with recognized standards.

However, I can extract the information that is present and note where the requested information is not provided.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing and Compliance with Standards)

The document states that "The test results show that all of the performance specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence."

While specific numerical acceptance criteria and reported device performance for individual metrics are not tabulated, the document generally indicates that the device met the requirements of several FDA-recognized consensus standards for medical electrical equipment and X-ray systems.

Here's a table summarizing the general approach taken, as specific performance criteria and reported values are not detailed in the provided text:

Acceptance Criteria Category (Implied by Standards)	Reported Device Performance (Summary from text)
System Integration and Functional Performance	Met all performance specifications and acceptance criteria.
Electrical Safety (IEC 60601-1)	Compliant with IEC 60601-1:2005+CORR. 1:2006+CORR.2:2007+A1:2012.
Electromagnetic Compatibility (EMC) (IEC 60601-1-2, IEC/TR 60601-4-2)	Compliant with IEC 60601-1-2:2014 and IEC/TR 60601-4-2 Edition 1.0 2016-05.
Radiation Protection (IEC 60601-1-3, IEC 60601-2-65, 21 CFR 1020.30 & 1020.31)	Complied with relevant radiation protection standards for diagnostic X-ray equipment and dental intraoral X-ray equipment. Leakage radiation reported as <0.25mGy/h at 1 meter.
Software Performance	All software specifications met acceptance criteria; verification and validation supported claims of substantial equivalence.
Manufacturing Quality System	Subject to Quality System (QS) regulation (21 CFR Part 820).

Additional Requested Information (Based on Provided Text):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document mentions "non-clinical testing, (integration and functional) including phantom tests," but does not specify the sample size of these tests or the provenance of the data. It explicitly states, "Clinical data is NOT required for a finding of substantial equivalence."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. The testing described is non-clinical and focused on device performance according to engineering specifications and regulatory standards, rather than diagnostic accuracy against a ground truth established by medical experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. This is typically relevant for diagnostic accuracy studies with human readers, which were not conducted for this 510(k) submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. The device is an X-ray source, not an AI-powered diagnostic tool. The submission states, "Clinical data is NOT required for a finding of substantial equivalence."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable for this device. This device is an X-ray generator, not an algorithm. Its performance is evaluated based on its physical properties and adherence to safety and performance standards.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical and phantom tests, the "ground truth" would be the engineering specifications and the expected output as defined by the relevant performance standards (e.g., measured radiation output within specified tolerance, electrical safety parameters met, software function as programmed). It is not medical ground truth established by experts.
The sample size for the training set:
- Not applicable/Not provided. This device is a hardware X-ray system with embedded control software. While software undergoes verification and validation, it is not an AI/machine learning algorithm that requires a separate "training set" for learning purposes in the way diagnostic AI models do.
How the ground truth for the training set was established:
- Not applicable/Not provided. As there is no AI/machine learning training set, this question is not relevant. The "ground truth" for the embedded software would be its correctly implemented functional requirements and specifications.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 8, 2024

Shenzhen Xpectvision Technology Co., Ltd. % Mr. Silver Cai Regulatory Affairs Manager B507, Block A&B, Nanshan Medical Device Industrial Park, Nanhai Avenue 1019, Nanshan District, SHENZHEN, GUANGDONG 518000 CHINA

Re: K233914

Trade/Device Name: XVbeam2000 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: December 12, 2023 Received: December 12, 2023

Dear Mr. Cai:

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 medical devices and radiation-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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K233914

Device Name XVbeam2000

Indications for Use (Describe)

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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Attachment 27 510(k) Summary

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510 (k) Summary - K233914

(As Required by 21 CFR 807.92)

1. Date Prepared

December 12, 2023

2. Submitter's Information

Company Name:	Shenzhen Xpectvision Technology Co., Ltd.
Company Address:	B507, Block A and B,Nanshan Medical Device Industrial Park,Nanhai Avenue 1019, Nanshan District,Shenzhen City, Guangdong Province, China.
Contact Person:	Silver Cai
Phone:	(+86) 0755-26897621
Email:	ra@xpectvision.com

3. Trade Name, Common Name, Classification

Trade/Model Name:	XVbeam2000
Common Name:	Handheld Dental X-ray System
Classification Name:	Extraoral source x-ray system
Regulation Number:	21 CFR 872.1800
Product Code:	EHD
Device Class:	Class II

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4. Identification of Predicate Device(s)

The identification predicates within this submission are as follows:

Manufacturer:	Aribex/ KaVo Dental Technologies, LLC
Trade/Model Name:	KaVo NOMAD Pro 2 Handheld X-ray System
Regulation Number:	21 CFR 872.1800
Product Code:	EHD
Classification Name:	Extraoral source x-ray system
FDA 510 (k) #:	K173319
Device Class:	Class II

5. Description of the Device

Image /page/5/Picture/5 description: The image shows a person receiving an oral cancer screening with a handheld device. The device is positioned near the person's mouth, emitting a light that illuminates the oral cavity. The device has a screen and several buttons on its surface. The person's face is visible, with their mouth slightly open to allow for the screening.

Figure 1. X-ray being generated by the XVbeam2000 during intraoral X-ray imaging

Note: image receptor is NOT part of the subject device

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The subject device is designed for use in a dental office or similar environments (hospital ward etc.) where appropriate safeguards are implemented.

The subject device XVbeam2000 is an X-ray device with a DC generator. The handheld device features a main body (X-ray tube head), rechargeable battery (handset), charger, and charger AC/DC power supply. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient. The power is supplied by a rechargeable Lithium-Ion battery core pack built into a handset. This facilitates portability of the device.

Image /page/6/Picture/2 description: The image shows a portable X-ray machine and its charging base on a wooden surface. The X-ray machine is white and gray with a black control panel and a clear, circular shield. The charging base is silver and white and has a cord plugged into it.

Figure 2. The left is photo of main body and beam-limiting cone of the device; and the right is the photo of charger.

Image /page/6/Figure/4 description: The image shows two views of a device, labeled as (a) Front view and (b) Lateral view. The front view shows a height of 220.53 and a width of 226.32. The lateral view shows a height of 98.79, a width of 129.64, and a length of 264.19.

Figure 3. Physical dimension of the device from two different views, the unit is in millimeter (mm).

Page 3 of 14

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To make the system as simple as possible for the operator, XVbeam2000 uses a fixed tube voltage of 65kV and a fixed tube current of 2.6mA. The only operator-adjustable parameter is the exposure time. This adjustment can be quickly accomplished through the user-friendly control panel. Control buttons, display, and a trigger provide the primary operator interface. Exposures settings can be selected and displayed. Voltage (65 kV) and current (2.6 mA) are fixed with the exposure time varying based on patient type, receptor type, and anatomical feature. Exposures can be completed using the trigger.

Image /page/7/Picture/1 description: The image shows a handheld dental X-ray device with a screen displaying dental imaging information. The screen shows a diagram of teeth, with some highlighted in blue, along with the word "Incisor" and two figures of people. The screen also displays the word "READY" and the number "0.01 s", along with a battery icon. Below the screen are several buttons, including plus and minus signs, a power button, a tooth icon, and a person icon.

Figure 4. Control panel and the display of the subject device; exposure time is pre-set depending on patient size, tooth group, and image receptor type. The exposure time can be adjusted by pressing the +/- buttons.

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6. Indications For Use

6.1 Indications for use

6.2 Suitable patient

General population (excluding pregnant women) who are evaluated by the dentist to need intraoral X-ray imaging examination.

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Characteristics	Predicate Device	Subject Device
Trade/Model Name	KaVo NOMAD Pro 2Handheld X-ray System	XVbeam2000
510(k) Number	K173319	/
Regulation Name	Extraoral Source X-raySystem	Same
ClassificationName	unit, x-ray, extraoral withtimer	Same
Common Name	Portable X-ray System	Handheld Dental X-raySystem
Product Code	EHD	Same
RegulationNumber	21 CFR 872.1800	Same
Review Panel	Radiology	Same
RegulationMedical Specialty	Dental	Same
Classification	II	Same
Indication for Use	The Kavo NOMAD Pro 2Handheld X-ray System isindicated for use only by atrained and qualified dentistor dental technician for bothadult and pediatric subjects asan extraoral diagnostic dentalX-ray source to produce X-ray images using intraoralimage receptors.	The Handheld Dental X-raySystem, model XVbeam2000,is indicated for use only by atrained and qualified dentistor dental technician as anextraoral X-ray source toproduce diagnostic X-rayimages using intraoral imagereceptors. Its use is intendedfor both adult and pediatricsubjects.
Intended usergroup	Trained and qualified dentistor dental technician	Same
Contact body site	The device does NOT directlycontact with humanbody/organ.Note: When used clinically,	Same
Characteristics	Predicate Device	Subject Device
	wrap, are used to isolateequipment from directcontact. Barriers should bechanged after each patient.The protective barrier isdisposable, and is NOT a partof this device.
Patient populations	General population (excludingpregnant women) who areevaluated by the dentist toneed intraoral X-ray imagingexamination.	Same
Appearance	Image: Predicate Device	Image: Subject Device
Dimension	279.4mm x 266.7mm x139.7mm	226.32mm x 220.53mm x129.64mm
Weight	2.7kg	2.1kg
Display	LCD panel Display	Same
User Interface	Up-down buttons for exposuretime selection, with timerdisplay. Additionally, severaluser-selectable preset timeswith patient size, image-receptor type, and toothselection icon on an LCDdisplay.	Same
Source to skindistance	21 cm	20 cm
Cone diameter	60mm	Same
Backscatterradiation protection	6.75" dia. Pb-filled acrylicplastic scatter shield	6.38" dia. Pb-filled acrylicplastic scatter shield
Characteristics	Predicate Device	Subject Device
Exposure switch	Trigger on handset	Exposure trigger at frontcover
Tubeheadmounting	Monoblock and Handheld	Same
X-ray Monoblock	X-ray Tube Model: KL11-0.4-70(Hangzhou Kailong)	Same
	Stationary Anode Focus: 0.4mm	Same
	Target Angle: 12°	Same
	Minimum permanentfiltration: 1.5 mm Al (inherentfiltration: 0.8mm glass,0.5mm Al, 0.2mm plastic cap)	Minimum permanentfiltration: 1.8 mm Al (inherentfiltration: 0.8mmAl)
	Tube Voltage: 60 kV fixed	Tube Voltage: 65 kV fixed
	Tube Current: 2.5 mA fixed	Tube Current: 2.6 mA fixed
Exposure TimeRange	0.02-1.0 seconds	0.01-2.0 seconds
Leakage radiation	<0.25mGy /h at 1 meter	Same
Energy Source	Rechargeable 21.6 V DCLithium-ion battery core pack	Rechargeable 22.2V DCLithium-ion polymer batterypack
Battery type	Rechargeable	Same
Casing	Hard shell case	Same
Connection method	Connector within handsetenclosure	Connector within base plateenclosure
Waveform	Constant Potential (DC)	Same
Duty Cycle	1:60	1:30
EMI Coating	Copper	Same
Electrical SafetyStandards	AAMI ES60601-1:2005/(R)2012 And A1:2012	Same
Characteristics	Predicate Device	Subject Device
EMI Standards	IEC60601-1-2 Ed. 4	IEC60601-1-2 Ed. 4IEC/TR60601-4-2
PerformanceStandard	21 CFR 1020.30,1020.31;IEC60601-1-3;IEC60601-2-65	Same
OperationConditions	Temperature: 10 to 40°C	Temperature: 10 to 40°C
	Humidity: 30 to 80% (Non-Condensing)	Humidity: 30 to 75%
	Atmospheric pressure: 80 to106 kPa	Atmospheric pressure: 70 to106 kPa
Storage andTransportationConditions	Temperature: -20 to 50°C	Temperature: -20 to 55°C
	Humidity: <90% (Non-Condensing)	Humidity: 10 to 93% (Non-Condensing)
	Atmospheric pressure: 80 to106 kPa	Atmospheric pressure: 70 to106 kPa

7. Comparable Technological Characteristics

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8. Non-clinical Performance Testing

Non-clinical testing, (integration and functional) including phantom tests were conducted for the subject device during product development. The general purpose of each tests is to verify and validate the performance and functionality of the subject device.

System Verification testings include:

System Integration Test (functional)
Functionality verification

System Validation testings include:

Acceptance test (workflow and user manual test)
Legal and Regulatory test

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Testing covers all related aspects that contribute to the device performance and functions. The test specification and acceptance criteria are related to the corresponding requirements. The test results show that all of the performance specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence.

A list of FDA-recognized consensus standards and general guidance documents considered for testing the subject device is listed as follows:

1. FDA-recognized consensus standards
- 60601-1:2005+CORR. ● IEC Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- IEC/TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical system.
- IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment -● Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
- IEC 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION ● Medical electrical equipment - Part 2-65: Requirements for the basic safety and essential performance of dental intraoral X-ray equipment.
1. FDA Guidance Documents
- Electronic Submission Template for Medical Device 510(k) ● Page 10 of 14

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Submissions: Guidance for Industry and Food and Drug Administration Staff, issued October 2, 2023

User Fees and Refunds for Premarket Notification Submissions (510(k)s): Guidance for Industry and Food and Drug Administration Staff, issued October 2, 2022
Appropriate Use of Voluntary Consensus Standards in Premarket ● Submissions for Medical Devices: Guidance for Industry and Food and Drug Administration Staff, issued September 14, 2018
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff, issued July 28, 2014
Device Labeling Guidance #G91-1 (Blue Book Memo), issued March 8, 1991
Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203), issued September 1, 1989
Guidance on Medical Device Patient Labeling: Final Guidance for O Industry and FDA Staff, issued April 19, 2001
Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff, issued June 6, 2022
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff, issued December 20, 2019
Content of Premarket Submissions for Device Software Functions: O Guidance for Industry and Food and Drug Administration Staff, issued June 14, 2023
Radiation Safety Considerations for X-ray Equipment Designed for 0 Hand-Held Use, issued December 24, 2008
0 Definition of General Purpose Radiographic X-Ray System - 21 CFR

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1020.30(b), issued March 1, 2005

Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 28, 2017
Guidance for Medical X-ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff, issued February 21, 2023
Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide, issued February 22, 2023
Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff, issued February 3, 2016

9. Electrical Safety and EMC Testing

Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the subject device in accordance with the following standards or guide document(s):

IEC 60601-1:2005+CORR. 1:2006+CORR.2:2007+A1:2012 Medical ● electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment -Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
. Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff. Page 12 of 14

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10. Software

The subject device incorporates embedded software. Tests are conducted for all software components developed in product development and for the complete product itself. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claims of substantial equivalence.

In accordance with "Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff", the software documentation is also included in this submission that covers the following aspects:

Software description
Software hazard analysis ●
Software requirements specifications ●
Software architecture design chart ●
Software design specifications ●
Software traceability analysis ●
Software development environment description ●
Verification & Validation testing
Revision level history ●
Unresolved anomalies .

This software involved in the subject device is only the embedded software that is used as the control software. The embedded software does NOT involve the information exchange with the hospital information system or platform, nor it supports the functionality of internet connection.

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11. Biocompatibility Information

The subject device does NOT contact directly with human body or organ, hence no biocompatibility testing was performed.

12. Sterility Information

No sterility testing was accomplished, as this device is not delivered sterile, nor does it require sterility.

13. Clinical Testing

Clinical data is NOT required for a finding of substantial equivalence.

14. Conclusion

As discussed above, the subject device Handheld Dental X-ray System, model XVbeam2000, employ the same fundamental technology and has a set of same or similar technological characteristics as the predicate device. The nonclinical data supports the safety of the device. The hardware and software verification and validation demonstrates that the subject device should perform as intended in the specified use conditions. The data included in this submission demonstrates that the subject device performs comparably to the predicate device currently marketed for the same intended use. The differences between the subject device and predicate device do not raise different questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.

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.