NewTom 5G
by Qr S.R.L.
510(k) K142222
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142222 | Date26 Jan 2015 | 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- Withdrawn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
- JAK
- 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 5G is a computed tomography system designed for medical imaging, specifically classified as a System, X-ray, Tomography, Computed device under FDA nomenclature. It employs X-ray technology to generate detailed cross-sectional images of anatomical structures, enabling precise diagnostic evaluations in radiology.
This device is intended for use in clinical radiology settings and is supplied as a reusable medical instrument. It has received FDA clearance under the 510(k) pathway, classified as a Class 2 Radiology device with product code JAK. The device is regulated under the traditional review process and is authorized for distribution in the United States.
Other devices from Qr S.R.L.
Questions
AI-generated answers, 1 Oct 2026
What is the NewTom 5G used for in clinical settings?
The NewTom 5G is a computed tomography system that uses X-ray technology to produce detailed cross-sectional images of anatomical structures. These images are essential for precise diagnostic evaluations in radiology, allowing clinicians to assess complex areas with high clarity and accuracy. Its design supports a wide range of applications, including dental, maxillofacial, and general radiology assessments.
Is the NewTom 5G a single-use or reusable device?
The NewTom 5G is supplied as a reusable medical instrument. Unlike single-use devices, it is built for repeated clinical use after proper cleaning, maintenance, and sterilization procedures. This design ensures long-term reliability and cost-effectiveness for healthcare facilities.
What regulatory pathway was followed for the NewTom 5G?
The NewTom 5G received FDA clearance under the 510(k) pathway, specifically classified as a Class 2 Radiology device with product code JAK. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in the United States.
How is the NewTom 5G different from other computed tomography systems?
The NewTom 5G distinguishes itself through its specialized design for high-resolution imaging, particularly suited for dental and maxillofacial applications. Its X-ray tomography technology provides detailed cross-sectional views, enabling clinicians to perform precise evaluations in radiology. The device’s reusable nature and FDA clearance further set it apart as a reliable choice for clinical settings.
What type of maintenance or care is required for the NewTom 5G?
As a reusable medical device, the NewTom 5G requires regular cleaning, maintenance, and sterilization to ensure optimal performance and safety. Healthcare providers must follow manufacturer guidelines for proper upkeep, including calibration checks and part replacements as needed. Adhering to these procedures extends the device’s lifespan and maintains its imaging accuracy.