(26 days)
K16063
No
The document describes a standard dental X-ray system and does not mention any AI/ML components or capabilities.
No.
The device is described as an intra-oral dental X-ray system intended for producing diagnostic dental radiographs, which is an imaging function, not a therapeutic one.
Yes
The intended use explicitly states the device is "for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures."
No
The device description explicitly lists hardware components such as an X-ray generator, X-ray controller, beam limiting device, operation panel, and mechanical arm, indicating it is a physical X-ray system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EzRay Air W is an intra-oral dental X-ray system. It uses X-rays to create images of the teeth, jaw, and other oral structures. This is an in vivo imaging technique, meaning it is performed on a living subject, not on a sample taken from the body.
- Intended Use: The intended use clearly states it is for "producing diagnostic dental radiographs." This is a form of medical imaging, not an in vitro diagnostic test.
Therefore, the EzRay Air W falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
EHD
Device Description
The EzRay Air W (Model: VEX-S300W) is an intra-oral dental X-ray system intended for intra-oral imaging, It consists of X-ray generator, X-ray controller, beam limiting device, operation panel and mechanical arm. The Xray controller allows for accurate exposure control, and the adjustable mechanical arm allows for easy positioning. 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
The performance test for the subject device, EzRay Air W (Model: VEX-S300W) and the predicate device, VEX-S100W (K123493) confirmed that the focal spot to skin distance for both devices were 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2017
VATECH Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K163705
Trade/Device Name: EzRay Air W (Model: VEX-S300W) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: December 23, 2016 Received: December 29, 2016
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K163705
Device Name EzRay Air W (Model: VEX-S300W)
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 7 – 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: December 09, 2016
3. Administrative Information
| Official Correspondent: | Dave Kim / Mtech Group
Address: 8310 Buffalo Speedway, Houston, TX 77025
Tel: +713-467-2607
Fax: +713-464-8880
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.co.kr) |
4. Device Information
| Type of 510(k) Submission: | Special |
|---|---|
| Trade or Proprietary Name: | EzRay Air W (Model: VEX-S300W) |
| 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: | VEX-S100W / K123493 |
| Reference device: | EzRay Air (Model: VEX-P300) / K16063 |
| 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 W (Model: VEX-S300W) is an intra-oral dental X-ray system intended for intra-oral imaging, It consists of X-ray generator, X-ray controller, beam limiting device, operation panel and mechanical arm. The Xray controller allows for accurate exposure control, and the adjustable mechanical arm allows for easy positioning. The system can be used with an imaging system.
7. Indication for use
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.
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| 8. Substantial Equivalence Chart | ||||
|---|---|---|---|---|
| Subject Device | Predicate Device | Reference Device | ||
| Device Name | EzRay Air W (Model: VEX- | |||
| S300W) | VEX-S100W | EzRay Air (Model: VEX- | ||
| P300) | ||||
| Applicant Name | VATECH Co., Ltd. | VATECH Co., Ltd. | VATECH Co., Ltd. | |
| 510(k) Number | N/A | K123493 | K161063 | |
| Device Classification | ||||
| Name | Extraoral source x-ray system | Extraoral source x-ray system | Extraoral source x-ray system | |
| Classification Product | ||||
| Code | EHD | EHD | EHD | |
| Regulation Number | 21 CFR 872.1800 | 21 CFR 872.1800 | 21 CFR 872.1800 | |
| Indications for Use | 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. | The VEX-S100W is an | |||
| extraoral source of X- | ||||
| rays, intended to be | ||||
| used for producing | ||||
| diagnostic dental | ||||
| radiographs for | ||||
| treatment of disease of | ||||
| the teeth, jaw and oral | ||||
| structures. | VEX-P300 is an extraoral | |||
| diagnostic dental X-ray | ||||
| source to produce X-ray | ||||
| images using intraoral | ||||
| image receptors. It is | ||||
| indicated for use by a | ||||
| dentist or a dental | ||||
| technician for both adult | ||||
| and pediatric patients. | ||||
| Minimum | ||||
| Source to skin | ||||
| distance | 200 mm | 1) 200 mm (default) |
- 300 mm (option) | 200 mm |
| Mech
anical | X-ray field Size
(default) | 60 mm round | 60 mm round | 60 mm round |
| | Focal spot | 0.4 mm | 0.4 mm | 0.4 mm |
| Minimum half-
value layer | | 1.5 mm Al | 1.5 mm Al | 1.5 mm Al |
| | Electric Power
Voltage | AC 100-240 V | AC 100-120 V / 200 -240 V | Rechargeable 22.2 V DC
Li-ion polymer battery
pack |
| | Rated Current | 10 A (at AC 250 V) | 16 A (at AC 250 V) | N/A |
| | Exposure time | 0.05 - 0.5 seconds in 0.01
increments | 0.04 - 2.0 seconds in
0.01 increments | 0.05 - 0.5 seconds in
0.01 increments |
| Electr
ical | Tube current | 2.5 or 3.0 mA fixed | 4 - 7 mA | 2.5 mA fixed |
| | Tube voltage | 65 kVp fixed | 50 - 70 kVp | 60 or 65 kVp fixed |
| | Operation mode | Manual Mode, Auto Mode | Manual Mode | Manual Mode, Auto Mode |
| | Applied
Standard | IEC 60601-1,
IEC 60601-1-3,
IEC 60601-2-65,
IEC 60601-1-2,
21 CFR 1020.30, 1020.31 | IEC 60601-1,
IEC 60601-1-3,
IEC 60601-2-65,
IEC 60601-1-2,
21 CFR 1020.30, 1020.31 | IEC 60601-1,
IEC 60601-1-3,
IEC 60601-2-65,
IEC 60601-1-2,
21 CFR 1020.30, 1020.31 |
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9. Performance Data
- Summary of Performance Testing
The performance test for the subject device, EzRay Air W (Model: VEX-S300W) and the predicate device, VEX-S100W (K123493) confirmed that the focal spot to skin distance for both devices were 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.