(58 days)
Not Found
No
The summary describes a standard handheld dental X-ray system and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
No.
The device is used to produce diagnostic X-ray images, not for therapeutic purposes.
No.
The device is an X-ray source used to produce diagnostic images, meaning it facilitates diagnosis but does not perform the diagnosis itself.
No
The device description explicitly states it is a "battery-operated, portable extraoral X-ray source system" with physical components like an "X-ray tube head," "rechargeable battery," "charger," and "beam-limiting cone." This indicates it is a hardware device that generates X-rays, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that this device is an X-ray source used to produce images of the inside of the mouth (intraoral). It does not analyze blood, tissue, or other bodily fluids or substances.
- The device's function is image generation, not diagnostic testing of biological samples. It provides an image that a trained professional then interprets for diagnosis.
The device is a medical imaging device, specifically a dental X-ray system.
N/A
Intended Use / 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.
Product codes
EHD
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
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.
General population (excluding pregnant women) who are evaluated by the dentist to need intraoral X-ray imaging examination.
Intended User / Care Setting
trained and qualified dentist or dental technician
dental office or similar environments (hospital ward etc.)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
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, IEC 60601-1-2:2014, IEC TR 60601-4-2 Edition 1.0 2016-05.
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.
Clinical data is NOT required for a finding of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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
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 |