Who is the manufacturer of XVbeam2000?

Shenzhen Xpectvision Technology Co., Ltd. filed the 510(k) submission for XVbeam2000 (K233914).

What is the FDA product code for XVbeam2000?

EHD. It is classified under 21 CFR 872.1800 as a Class 2 device in the Dental panel.

What is the regulatory pathway for XVbeam2000?

510(k) clearance (submission type: Traditional).

What are the predicate devices for XVbeam2000?

KaVo NOMAD Pro 2 Handheld X-ray System (K173319).

Who can help prepare an FDA 510(k) submission like XVbeam2000?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

XVbeam2000

K233914 · Shenzhen Xpectvision Technology Co., Ltd. · EHD · Feb 8, 2024 · Dental

Device Facts

Record ID	K233914
Device Name	XVbeam2000
Applicant	Shenzhen Xpectvision Technology Co., Ltd.
Product Code	EHD · Dental
Decision Date	Feb 8, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.1800
Device Class	Class 2
Attributes	Pediatric

Intended Use

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 Story

Portable, battery-operated handheld dental X-ray system; generates X-rays for diagnostic intraoral imaging. Used in dental offices or hospital wards by dentists/technicians. Device comprises X-ray tube head, rechargeable Li-ion battery handset, and beam-limiting cone. Operator selects exposure time via control panel; voltage (65kV) and current (2.6mA) are fixed. Exposure triggered by user. Internal/external shielding protects clinician during operation. Compatible with film, digital sensors, and phosphor plates. Benefits include portability and simplified operation for intraoral imaging.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including system integration, functional verification, and phantom testing to validate performance against consensus standards.

Technological Characteristics

Portable DC X-ray generator; 65kV fixed voltage, 2.6mA fixed current. Stationary anode (0.4mm focus, 12° target angle). 1.8mm Al minimum filtration. Rechargeable 22.2V Li-ion polymer battery. Pb-filled acrylic scatter shield. Dimensions: 226.32 x 220.53 x 129.64 mm. Weight: 2.1kg. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-65.

Indications for Use

Indicated for adult and pediatric patients (excluding pregnant women) requiring intraoral X-ray imaging, for use by trained dentists or dental technicians.

Regulatory Classification

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.

Predicate Devices

KaVo NOMAD Pro 2 Handheld X-ray System (K173319)

Related Devices

K173319 — KaVo NOMAD Pro 2 Handheld X-ray System · Aribex · Nov 16, 2017
K253864 — NOMAD Pro 3 · Dental Imaging Technologies Corporation · Mar 20, 2026
K213282 — ERI Handheld Dental X-ray System (Model AG100) · Energy Resources International Co., Ltd. Hsinchu Branch · Apr 4, 2022
K141497 — PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) · Osstem Implant Co., Ltd. · Aug 26, 2014
K242591 — XERO-alpha · DRTECH Corporation · Nov 1, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K233914 Device Name XVbeam2000 #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Attachment 27 510(k) Summary {4}------------------------------------------------ # 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 | {5}------------------------------------------------ ## 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 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. 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 {6}------------------------------------------------ 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 {7}------------------------------------------------ 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. {8}------------------------------------------------ ## 6. Indications For Use #### 6.1 Indications for use 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. # 6.2 Suitable patient General population (excluding pregnant women) who are evaluated by the dentist to need intraoral X-ray imaging examination. {9}------------------------------------------------ | Characteristics | Predicate Device | Subject Device | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade/Model Name | KaVo NOMAD Pro 2 Handheld X-ray System | XVbeam2000 | | 510(k) Number | K173319 | / | | Regulation Name | Extraoral Source X-ray System | Same | | Classification Name | unit, x-ray, extraoral with timer | Same | | Common Name | Portable X-ray System | Handheld Dental X-ray System | | Product Code | EHD | Same | | Regulation Number | 21 CFR 872.1800 | Same | | Review Panel | Radiology | Same | | Regulation Medical Specialty | Dental | Same | | Classification | II | Same | | Indication for Use | The Kavo NOMAD Pro 2 Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X- ray images using intraoral image receptors. | 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. | | Intended user group | Trained and qualified dentist or dental technician | Same | | Contact body site | The device does NOT directly contact with human body/organ. Note: When used clinically, | Same | | Characteristics | Predicate Device | Subject Device | | | wrap, are used to isolate equipment from direct contact. Barriers should be changed after each patient. The protective barrier is disposable, and is NOT a part of this device. | | | Patient populations | General population (excluding pregnant women) who are evaluated by the dentist to need intraoral X-ray imaging examination. | Same | | Appearance | Image: Predicate Device | Image: Subject Device | | Dimension | 279.4mm x 266.7mm x 139.7mm | 226.32mm x 220.53mm x 129.64mm | | Weight | 2.7kg | 2.1kg | | Display | LCD panel Display | Same | | User Interface | Up-down buttons for exposure time selection, with timer display. Additionally, several user-selectable preset times with patient size, image- receptor type, and tooth selection icon on an LCD display. | Same | | Source to skin distance | 21 cm | 20 cm | | Cone diameter | 60mm | Same | | Backscatter radiation protection | 6.75" dia. Pb-filled acrylic plastic scatter shield | 6.38" dia. Pb-filled acrylic plastic scatter shield | | Characteristics | Predicate Device | Subject Device | | Exposure switch | Trigger on handset | Exposure trigger at front cover | | Tubehead mounting | Monoblock and Handheld | Same | | X-ray Monoblock | X-ray Tube Model: KL11- 0.4-70(Hangzhou Kailong) | Same | | | Stationary Anode Focus: 0.4 mm | Same | | | Target Angle: 12° | Same | | | Minimum permanent filtration: 1.5 mm Al (inherent filtration: 0.8mm glass, 0.5mm Al, 0.2mm plastic cap) | Minimum permanent filtration: 1.8 mm Al (inherent filtration: 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 Time Range | 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 DC Lithium-ion battery core pack | Rechargeable 22.2V DC Lithium-ion polymer battery pack | | Battery type | Rechargeable | Same | | Casing | Hard shell case | Same | | Connection method | Connector within handset enclosure | Connector within base plate enclosure | | Waveform | Constant Potential (DC) | Same | | Duty Cycle | 1:60 | 1:30 | | EMI Coating | Copper | Same | | Electrical Safety Standards | 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. 4 IEC/TR60601-4-2 | | Performance Standard | 21 CFR 1020.30,1020.31; IEC60601-1-3; IEC60601-2-65 | Same | | Operation Conditions | Temperature: 10 to 40°C | Temperature: 10 to 40°C | | | Humidity: 30 to 80% (Non- Condensing) | Humidity: 30 to 75% | | | Atmospheric pressure: 80 to 106 kPa | Atmospheric pressure: 70 to 106 kPa | | Storage and Transportation Conditions | Temperature: -20 to 50°C | Temperature: -20 to 55°C | | | Humidity: <90% (Non- Condensing) | Humidity: 10 to 93% (Non- Condensing) | | | Atmospheric pressure: 80 to 106 kPa | Atmospheric pressure: 70 to 106 kPa | # 7. Comparable Technological Characteristics {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ ## 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 {13}------------------------------------------------ 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. - 2) FDA Guidance Documents - Electronic Submission Template for Medical Device 510(k) ● Page 10 of 14 {14}------------------------------------------------ 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 {15}------------------------------------------------ 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 {16}------------------------------------------------ #### 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. {17}------------------------------------------------ #### 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.