Dental Digital PANORAMIC/3D Imaging System
by E-Woo Technology 510(k)
Active
510(k) K070658
Overview
The Dental Digital Panoramic/3D Imaging System is a Class II computed tomography (CT) scanner designed for dental radiography. It provides panoramic and three-dimensional imaging of the maxillofacial region, including teeth, jaws, and surrounding structures, enabling detailed assessment for diagnostic and treatment planning purposes. This system generates high-resolution images to support evaluations of dental anatomy, pathology, and orthodontic or surgical planning. Its integration of panoramic and volumetric imaging allows clinicians to visualize both broad and fine anatomical details in a single session.
This device is intended for use in dental and maxillofacial radiology settings, where it is operated by trained radiographers or dental professionals. Supplied as a reusable medical device, it requires proper calibration and maintenance to ensure accurate imaging output. The system has received FDA 510(k) clearance under the Radiology Device Facts category, confirming its substantial equivalence to a predicate device. No specific sterility or single-use requirements are noted; however, adherence to standard radiation safety protocols and facility guidelines is essential for operation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070658 | Date5 Apr 2007 | 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- Withdrawn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 Dental Digital Panoramic/3D Imaging System used for?
This system is designed for dental and maxillofacial radiology, providing panoramic and three-dimensional imaging of the teeth, jaws, and surrounding structures. It supports detailed diagnostic evaluations and treatment planning, including orthodontics and surgical assessments, by delivering high-resolution images of both broad and fine anatomical details in a single session.
Is the E-Woo Dental Digital Panoramic/3D Imaging System single-use or reusable?
The device is supplied as a reusable medical device. While no specific sterility requirements are mentioned, it must be properly calibrated and maintained to ensure accurate imaging output and comply with facility guidelines for reuse.
What regulatory clearance does this imaging system hold?
The system has received FDA 510(k) clearance under the Radiology Device Facts category, confirming its substantial equivalence to a predicate device. This clearance was granted through a traditional review process by the Radiology Advisory Committee (RA).
What safety protocols should be followed when operating this device?
Since this is a computed tomography scanner, strict adherence to radiation safety protocols is mandatory. Operators, typically trained radiographers or dental professionals, must follow facility-specific guidelines to minimize exposure and ensure safe operation.
Does this system integrate panoramic and volumetric imaging capabilities?
Yes, the system combines panoramic and volumetric imaging, allowing clinicians to visualize both wide anatomical regions and fine structural details in a single imaging session. This dual capability enhances diagnostic accuracy and treatment planning efficiency.