NewTom 3G QR-DVT 9000
510(k) K041137
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041137 | Date14 May 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- OAS
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The NewTom 3G QR-DVT 9000 is a Computed Tomography X-ray System, Dental, designed for odontiatric radiology. It acquires a full 360-degree rotational X-ray sequence to generate detailed cross-sectional images, enabling precise diagnostic evaluation of dental structures and pathologies. The system is specifically configured for dental applications, including assessment of bone density, implant planning, and monitoring of dental implants.
This device is supplied as a reusable medical imaging system intended for use in radiology settings. It operates under regulatory oversight as a Class 2 device (product code OAS) and holds an FDA 510(k) clearance through the Special pathway. The system requires proper calibration, maintenance, and adherence to radiation safety protocols. No sterility or single-use specifications are indicated, and MRI safety data is not provided.
Other devices from Aperio Services, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the primary use of the NewTom 3G QR-DVT 9000 in dental radiology?
The NewTom 3G QR-DVT 9000 is designed to acquire detailed cross-sectional images of dental structures through a full 360-degree rotational X-ray sequence. This capability enables clinicians to evaluate bone density, plan dental implants, and monitor implant progress with high precision. The system’s advanced imaging ensures accurate diagnostic assessments for complex dental pathologies.
Is the NewTom 3G QR-DVT 9000 a single-use or reusable device?
The NewTom 3G QR-DVT 9000 is supplied as a reusable medical imaging system. It is intended for use in radiology settings and requires proper calibration, maintenance, and adherence to radiation safety protocols to ensure consistent performance and patient safety over repeated use.
What regulatory pathway does the NewTom 3G QR-DVT 9000 follow?
The NewTom 3G QR-DVT 9000 holds FDA 510(k) clearance through the Special pathway and is classified as a Class 2 device under product code OAS. This classification reflects its role in dental radiology, where it is used for diagnostic imaging without requiring sterility or single-use specifications.
Does the NewTom 3G QR-DVT 9000 include MRI safety data?
The provided documentation does not include MRI safety data for the NewTom 3G QR-DVT 9000. Clinicians should ensure compatibility with their facility’s MRI protocols and follow radiation safety guidelines when using this device, as it is designed exclusively for X-ray-based dental imaging.
What maintenance considerations are important for the NewTom 3G QR-DVT 9000?
The NewTom 3G QR-DVT 9000 requires regular calibration and maintenance to ensure accurate imaging and radiation safety. Manufacturers recommend following the provided operational manuals and adhering to radiation safety protocols to maintain optimal performance. Proper training for staff handling the device is also essential to prevent equipment misuse or malfunctions.