X-Mind DC
by de Götzen S.r.l. EUDAMED510(k)
Active
510(k) K231055
Overview
The X-Mind DC is an Extraoral X-Ray Unit with Timer, designed for dental radiography. This device captures high-quality radiographic images of dental structures, including teeth and surrounding bone, using controlled exposure settings and an integrated timer to ensure precise imaging.
Intended for use in dental clinics and offices, the X-Mind DC is supplied as a reusable medical device. It operates under FDA 510(k) clearance and MDR compliance, with a classification as a Class II device. The system is non-MRI compatible and requires proper storage in a clean, dry environment to maintain functionality and sterility.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK231055 | Date28 Dec 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Full name
- x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
- 510(k) Number
- FDA Product Code
- EHD
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from de Götzen S.r.l.
Questions
Is the X-Mind DC device single-use or reusable, and what does that mean for maintenance and cleaning?
The X-Mind DC is designed as a reusable medical device, meaning it is built to be used multiple times after proper cleaning and maintenance. Since it is not sterile by default, it must be cleaned and disinfected according to the manufacturer’s instructions between uses to ensure hygiene and functionality. This approach allows for cost-effective use in dental clinics while maintaining safety standards.
What storage conditions are required to keep the X-Mind DC in optimal working condition?
The X-Mind DC should be stored in a clean, dry environment to preserve its functionality and prevent damage. Avoid exposing it to moisture, extreme temperatures, or direct sunlight, as these conditions could affect performance or sterility if the device is prepared for use in a sterile field (e.g., with disposable barriers). Proper storage also helps maintain the device’s longevity and reliability for dental radiography.
Can this device be used in an MRI environment, and if not, what precautions should be taken?
The X-Mind DC is not MRI-compatible, meaning it should never be brought into an MRI scanning area. This is because the device contains metallic or electronic components that could interfere with MRI imaging or pose a safety risk to patients. Clinics must ensure the device remains outside MRI zones and follow facility protocols for non-MRI-compatible equipment.
What regulatory pathways does the X-Mind DC follow, and how does that affect its use in the U.S.?
The X-Mind DC follows FDA 510(k) clearance and MDR compliance, classifying it as a Class II device under the U.S. regulatory system. This means it has undergone rigorous review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for dental radiography. Clinicians can rely on its regulatory status as proof of compliance with U.S. medical device regulations.