X-View Extraoral Source X-Ray System
510(k) K024186
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK024186 | Date1 Apr 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- X-View
- 510(k) Number
- FDA Product Code
- MUH
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The X-View is a digital extraoral X-ray imaging system designed for dental radiography. It captures high-resolution images of the jaw, teeth, and surrounding structures using an external X-ray source and digital detection technology, enabling precise diagnostic evaluation for dental professionals.
This system is intended for use in dental offices and clinics, providing single-use or reusable components as specified by the manufacturer. It operates under FDA 510(k) clearance (K024186) and falls under regulation 21 CFR 872.1800, classified as a Class II medical device. The system is supplied with various FEI numbers and registration identifiers, ensuring compliance with dental imaging standards.
Other devices from Sometech Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the X-View digital extraoral X-ray system used for?
The X-View is designed specifically for dental radiography, capturing high-resolution images of the jaw, teeth, and surrounding structures. This enables dental professionals to perform precise diagnostic evaluations, such as identifying dental caries, assessing bone structure, or planning treatments like extractions or implants.
How are the components of the X-View system supplied?
The X-View system is supplied with a range of components, including multiple FEI numbers (e.g., 3000190675, 3038718579) and registration identifiers. The manufacturer specifies whether individual components are single-use or reusable, ensuring compliance with dental imaging standards and regulatory requirements.
Is the X-View system sterile upon delivery?
The sterility of the X-View system components depends on the specific part and manufacturer guidelines. Single-use components are typically sterile-packaged, while reusable parts require cleaning, disinfection, or sterilization before use. Always follow the manufacturer’s instructions for proper handling and reprocessing.
What regulatory approval does the X-View system hold?
The X-View system holds FDA 510(k) clearance under the reference number K024186, classified as a Class II medical device under regulation 21 CFR 872.1800. This clearance confirms its substantial equivalence to a predicate device and compliance with dental imaging standards.
How do I determine the correct model or FEI number for my X-View system?
The X-View system includes multiple FEI numbers (e.g., 3000190675, 3014544225) and registration identifiers for different components. These identifiers are used for inventory, compliance, and regulatory tracking. Check the packaging or documentation provided with your system to match the correct FEI number to the specific part or module you need.