X-MIND Prime 3D
by de Götzen S.r.l. EUDAMED510(k)
Active
510(k) K201382
Overview
The X-MIND Prime 3D is a computed tomography X-ray device for dental imaging, designed to capture both two-dimensional panoramic radiographs and three-dimensional cone-beam volumetric tomography (CBVT) of teeth, jaws, and oral structures. It functions as an extra-oral unit, enabling detailed radiographic examinations for diagnostic purposes in dental and maxillofacial assessments.
This device is supplied as a reusable medical instrument and is intended for use in clinical radiology settings. It operates under FDA 510(k) clearance and EU MDR compliance, with a classification as a Class II device. The system requires proper calibration and maintenance in accordance with manufacturer guidelines, and its use is governed by radiologic safety protocols to ensure accurate imaging and patient protection.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK201382 | Date18 Nov 2020 | 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- Withdrawn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 prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
- 510(k) Number
- FDA Product Code
- OAS
- FDA applicant
- De Gotzen S.R.L.
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
X-MIND® Prime 3D -. X-MIND® prime 3D is a new generation CBCT all-in-one dental unit. It is featuring stylish and smooth design underlying a cutting-edge technology. With X-MIND ® prime 3D you will take advange from a streamlined acquisition workflow.
Official Acteon documentation — X-Mind prime 3D (3D ＆ Panoramic imaging). Download user manuals, brochures and certifications for this product.
Other devices from de Götzen S.r.l.
Questions
What types of dental imaging can the X-MIND prime 3D device perform, and how does it differ from traditional X-ray methods?
The X-MIND prime 3D device is designed to capture both two-dimensional panoramic radiographs and three-dimensional cone-beam volumetric tomography (CBVT) of teeth, jaws, and oral structures. Unlike traditional 2D X-rays, which provide flat images, this device offers detailed cross-sectional views, enabling more comprehensive assessments of dental and maxillofacial anatomy for diagnostic purposes.
Is the X-MIND prime 3D device reusable, and what maintenance or calibration requirements should be considered?
Yes, the X-MIND prime 3D is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical settings. Proper calibration and maintenance are required to ensure accurate imaging and patient safety, as outlined in the manufacturer’s guidelines. Adherence to radiologic safety protocols is also essential for optimal performance.
What regulatory pathways has the X-MIND prime 3D device followed, and what does this mean for its use in clinical settings?
The device has undergone FDA 510(k) clearance and complies with EU MDR (Medical Device Regulation), classifying it as a Class II device. This means it has been evaluated for safety and effectiveness by regulatory authorities, ensuring it meets established standards for dental computed tomography imaging in radiology settings.
Are there different models or configurations available for the X-MIND prime 3D, and how might they differ?
The device is marketed under two trademarks: X-MIND prime 3D (Acteon) and I-MAX 3D (Owandy Radiology), but no specific differences in technical specifications or capabilities are detailed in the provided data. Both versions are intended for the same core function—extra-oral dental CT imaging—and likely share the same regulatory compliance and performance standards.