EzRay Air Portable VEX-P300
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200182 FDA 510(k)
- FDA Product Code
- EHD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1800 FDA 510(k)
- Regulation Number
- 872.1800 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EzRay Air Portable VEX-P300 is an extraoral X-ray unit with a built-in timer, designed for dental imaging. It produces radiographic images of the maxillofacial region, aiding in the diagnosis of dental and skeletal conditions by capturing high-resolution images of teeth, jaws, and surrounding structures.
This portable device is intended for use in dental clinics and offices by certified professionals. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure accurate imaging. The EzRay Air Portable VEX-P300 is classified as a Class II device under FDA regulations and has received 510(k) clearance and MDR authorization, adhering to strict safety and performance standards for dental X-ray systems.
Frequently asked questions
Is the EzRay Air Portable VEX-P300 designed for single-use or can it be reused in a clinical setting?
The EzRay Air Portable VEX-P300 is supplied as a reusable medical device, meaning it is intended for repeated use in dental clinics after proper cleaning, maintenance, and calibration. Since it is classified as a reusable Class II device, it must adhere to strict protocols to ensure safety, performance, and hygiene between uses.
What types of images can the EzRay Air Portable VEX-P300 capture, and what regions of the mouth does it focus on?
The EzRay Air Portable VEX-P300 is an extraoral X-ray unit specifically designed for capturing high-resolution images of the maxillofacial region, including teeth, jaws, and surrounding skeletal structures. It aids in diagnosing dental and skeletal conditions by providing detailed radiographic views of these areas.
How is the EzRay Air Portable VEX-P300 regulated, and what does its classification mean for users?
The EzRay Air Portable VEX-P300 is classified as a Class II medical device under FDA regulations and has received 510(k) clearance as well as MDR authorization. This classification means it undergoes rigorous review to ensure safety and effectiveness, and users must follow manufacturer guidelines for proper operation, maintenance, and calibration to comply with regulatory standards.
Does the EzRay Air Portable VEX-P300 come with built-in safety features, and what role does the timer play in its operation?
Yes, the EzRay Air Portable VEX-P300 includes a built-in timer, which helps control exposure time during imaging. This feature ensures consistent and safe radiographic exposure while capturing clear images of the maxillofacial region, reducing the risk of overexposure or underexposure.
What should clinicians consider when storing or maintaining the EzRay Air Portable VEX-P300?
Since the EzRay Air Portable VEX-P300 is a reusable device, proper storage and maintenance are critical to ensure its longevity and performance. Clinicians should follow manufacturer instructions for cleaning, calibration, and periodic inspections to maintain accuracy and safety. Additionally, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EzRay Air Portable VEX-P300 User Manual, English - Vatech America, Vatech EzRay Air VEX-P300 Manuals | ManualsLib, EzRay Air Portable - Intra-oral Imaging Systems - VATECH
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K200182 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vatech Co., Ltd.
Sources (2)
- FDA 510(k) K200182 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026