(26 days)
Not Found
No
The document describes a standard dental X-ray system and its performance characteristics, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
No.
The device is an X-ray system used for producing diagnostic images, not for therapy or treatment.
Yes
The device is described as producing "diagnostic dental radiographs" for the treatment of diseases of the teeth, jaw, and other oral structures. This explicitly states its diagnostic purpose.
No
The device description explicitly states it consists of hardware components such as an X-ray generator, X-ray controller, beam limiting device, operation panel, and mechanical arm. While it uses software (firmware), it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce diagnostic dental radiographs for the treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors. This involves generating X-rays and capturing images of the internal structures of the body.
- Device Description: The device is described as a dental X-ray system consisting of components like an X-ray generator, controller, and mechanical arm. It's used for intra-oral imaging.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
This device operates by generating radiation to create images of internal structures, which is a form of in vivo diagnostic imaging, not in vitro testing.
N/A
Intended Use / Indications for Use
The EzRay Air 2 Wall (Model Name: VEX-S350W) is a dental X-ray system intended for use by a trained and qualified dentist or dental technician for both and pediatric subjects for producing diagnostic dental radiographs for the treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
Product codes (comma separated list FDA assigned to the subject device)
EHD
Device Description
The EzRay Air 2 Wall (Model: VEX-S350W) is a dental X-ray system intended for intra-oral imaging. It consists of an X-ray generator, X-ray controller, beam limiting device, operation panel, and mechanical arm. The X-ray controller allows for accurate exposure control, and the adjustable mechanical arm allows for easy positioning. The functions of the VEX-S350W intra-oral system are supported by software (firmware). The software is based on the predicate device and is of Moderate level of concern. The system can be used with an imaging system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, and other oral structures
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
trained and qualified dentist or dental technician
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)
The performance test for the subject device, EzRay Air 2 Wall (Model: VEX-S350W) and the predicate device, VEX-S300W (K163705) confirmed that the focal spot to skin distance for both devices was longer than the minimum length of 20 cm. Accuracy of loading factors and reproducibility of Air KERMA for both X-ray systems also met the essential performance requirements (ex.
§ 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
October 26, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
VATECH Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin Street, Suite 610 HOUSTON TX 77054
Re: K223058
Trade/Device Name: EzRay Air 2 Wall (Model: VEX-S350W) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: September 22, 2022 Received: September 30, 2022
Dear Mr. Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk, 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
Enclosure
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Indications for Use
510(k) Number (if known) K223058
Device Name EzRay Air 2 Wall (Model: VEX-S350W)
Indications for Use (Describe)
The EzRay Air 2 Wall (Model Name: VEX-S350W) is a dental X-ray system intended for use by a trained and qualified dentist or dental technician for both and pediatric subjects for producing diagnostic dental radiographs for the treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. Special 510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
2. Date 510K Summary prepared: October 20, 2022
3. Administrative Information
| Official Correspondent: | Dave Kim / Mtech Group |
|---|---|
| Address: 7505 Fannin Street, Suite 610, | |
| Houston, TX 77025 | |
| Tel: +713-467-2607 | |
| Contact person: Mr. Dave Kim (davekim@mtech-inc.net) | |
| 510(k) Submitter: | VATECH Co., Ltd. |
| Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, | |
| Gyeonggi-do, 18449, Korea | |
| Tel: +82-31-379-9492 | |
| Fax: +82-31-379-9400 | |
| Contact person: Daniel Kim / Manager (daniel.kim@vatech.com) |
- Device Information
| Type of 510(k) Submission: | Special |
|---|---|
| Trade or Proprietary Name: | EzRay Air 2 Wall (Model: VEX-S350W) |
| Common or Usual Name: | Dental X-ray system |
| Regulation Classification: | Extraoral source X-ray system (21 CFR 872.1800) |
| Product Code: | EHD |
| Class of Device: | Class II |
| Panel: | Radiology |
5. Predicate Device Information
| Manufacturer: | VATECH Co., Ltd. |
|---|---|
| Predicate device: | EzRay Air Wall (Model: VEX-S300W) / K163705 |
| Common or Usual Name: | Dental X-ray system |
| Regulation Classification: | Extraoral source X-ray system (21 CFR 872.1800) |
| Product Code: | EHD |
| Class of Device: | Class II |
| Panel: | Radiology |
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6. Device Description
The EzRay Air 2 Wall (Model: VEX-S350W) is a dental X-ray system intended for intra-oral imaging. It consists of an X-ray generator, X-ray controller, beam limiting device, operation panel, and mechanical arm. The X-ray controller allows for accurate exposure control, and the adjustable mechanical arm allows for easy positioning. The functions of the VEX-S350W intra-oral system are supported by software (firmware). The software is based on the predicate device and is of Moderate level of concern. The system can be used with an imaging system.
7. Indication for use
The EzRay Air 2 Wall (Model Name: VEX-S350W) is a dental X-ray system intended for use by a trained and qualified dentist or dental technician for both adult and pediatric subjects for producing diagnostic dental radiographs for the treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
5
| 8. Substantial Equivalence Chart | Subject Device | Predicate Device | |
|---|---|---|---|
| Device Name | EzRay Air 2 Wall (Model: VEX-S350W) | EzRay Air Wall (Model: VEX-S300W) | |
| Applicant Name | VATECH Co., Ltd. | VATECH Co., Ltd. | |
| 510(k) Number | N/A | K163705 | |
| Device Classification Name | Extraoral source x-ray system | Extraoral source x-ray system | |
| Classification Product Code | EHD | EHD | |
| Regulation Number | 21 CFR 872.1800 | 21 CFR 872.1800 | |
| Indications for Use | The EzRay Air 2 Wall (Model: VEX- | ||
| S350W) is a dental X-ray system | |||
| intended for use by a trained and | |||
| qualified dentist or dental technician | |||
| for both adult and pediatric subjects | |||
| for producing diagnostic dental | |||
| radiographs for the treatment of | |||
| diseases of the teeth, jaw, and other | |||
| oral structures using intra-oral image | |||
| receptors. | The EzRay Air W (Model: VEX-S300W) | ||
| is an intra-oral dental X-ray system | |||
| (extra-oral X-ray source system) | |||
| intended for use by a trained and | |||
| qualified dentist or dental technician | |||
| for both adult and pediatric subjects | |||
| for producing diagnostic dental | |||
| radiographs for treatment of diseases | |||
| of the teeth, jaw, and other oral | |||
| structures using intra-oral image | |||
| receptors. | |||
| Minimum Source to | |||
| skin distance | 200 mm | 200 mm | |
| Mec | |||
| hani | |||
| cal | X-ray field Size | ||
| (default) | 60 mm round | 60 mm round | |
| Focal spot | 0.4 mm | 0.4 mm | |
| Minimum half- | |||
| value layer | 1.5 mm Al | 1.5 mm Al | |
| Electric Power | |||
| Voltage | AC 100-240 V | AC 100-240 V | |
| Rated Current | 10 A (at AC 250 V) | 10 A (at AC 250 V) | |
| Elect | |||
| rical | Exposure time | 0.05 - 2.0 seconds in 0.01 | |
| increments | 0.05 - 0.5 seconds in 0.01 | ||
| increments | |||
| Tube current | 5.0 mA fixed | 2.5 or 3.0 mA fixed | |
| Tube voltage | 65 / 70 kVp fixed | 65 kVp fixed | |
| Operation mode | Manual Mode | Manual Mode, Auto Mode | |
| Applied Standard | IEC 60601-1, | ||
| IEC 60601-1-3, | |||
| IEC 60601-2-65, | |||
| IEC 60601-1-2, | IEC 60601-1, | ||
| IEC 60601-1-3, | |||
| IEC 60601-2-65, | |||
| IEC 60601-1-2, | |||
| 21 CFR 1020.30, 1020.31 | 21 CFR 1020.30, 1020.31 |
8. Substantial Equivalence Chart
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9. Performance Data
- Summary of Performance Testing
The performance test for the subject device, EzRay Air 2 Wall (Model: VEX-S350W) and the predicate device, VEX-S300W (K163705) confirmed that the focal spot to skin distance for both devices was longer than the minimum length of 20 cm. Accuracy of loading factors and reproducibility of Air KERMA for both X-ray systems also met the essential performance requirements (ex.