Computed Tomography X-Ray System, Model Picasso-Duo
by E-Woo Technology 510(k)
Active
510(k) K090991
Overview
The Computed Tomography X-Ray System, Model Picasso-Duo is a diagnostic imaging device classified as a computed tomography (CT) scanner, designed to generate cross-sectional and panoramic images of dental and maxillofacial structures. It reconstructs x-ray transmission data from axial planes to facilitate detailed examination and diagnosis of teeth, jaws, and oral anatomy. This system is intended for use in radiology settings to provide high-resolution imaging for dental and maxillofacial evaluations.
The device is supplied as a Class II medical product and has received FDA 510(k) clearance under K-number K090991, determined to be substantially equivalent to a predicate device. It is intended for single-use or reusable applications in controlled clinical environments, adhering to regulatory standards for computed tomography systems. The system is not explicitly noted for MRI compatibility or sterility requirements in available data, and its operational specifications align with the product code JAK under the classification name System.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK090991 | Date9 Oct 2009 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JAK
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from E-Woo Technology
Questions
What is the Picasso-Duo CT X-ray system designed for?
The Picasso-Duo CT X-ray system is specifically designed for generating detailed cross-sectional and panoramic images of dental and maxillofacial structures. It aids in the examination and diagnosis of teeth, jaws, and oral anatomy by reconstructing x-ray transmission data from axial planes. This makes it particularly useful in radiology settings for evaluating complex oral and maxillofacial conditions.
How is the Picasso-Duo CT X-ray system supplied and intended for use?
The Picasso-Duo is supplied as a Class II medical device and is intended for use in controlled clinical environments. It is designed for either single-use or reusable applications, depending on the clinical workflow and regulatory compliance requirements. The system adheres to standards for computed tomography devices, ensuring safety and reliability in diagnostic imaging.
Is the Picasso-Duo CT X-ray system sterile or MRI-compatible?
The available data does not explicitly state that the Picasso-Duo CT X-ray system is sterile or MRI-compatible. Sterility requirements are typically dependent on the specific clinical setting and handling procedures. For MRI compatibility, this would need to be confirmed with the manufacturer, as the system is not noted for such compatibility in the provided information.
What regulatory clearance does the Picasso-Duo CT X-ray system hold?
The Picasso-Duo CT X-ray system has received FDA 510(k) clearance under K-number K090991. This clearance was determined based on substantial equivalence to a predicate device, following a traditional review process by the FDA’s Radiology Advisory Committee. The system is classified under product code JAK as a computed tomography imaging system.
What are the key specifications or features of the Picasso-Duo CT X-ray system?
The Picasso-Duo is a computed tomography scanner focused on dental and maxillofacial imaging, providing high-resolution cross-sectional and panoramic views. It operates under the classification of a Class II medical device and is intended for use in radiology settings. The system’s design emphasizes detailed anatomical visualization, supporting diagnostic evaluations of oral structures.