Bennett X-Ray Tomography System
510(k) K945749
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK945749 | Date15 Feb 1995 | 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- Withdrawn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
- IZF
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1740
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Bennett X-Ray Tomography System is a Class II medical device classified as an X-Ray Tomographic System. It produces radiologic images of specific cross-sectional planes within the body by selectively blurring or eliminating detail from adjacent planes, enabling detailed visualization of targeted anatomical structures. This system incorporates signal analysis and display equipment, patient positioning supports, and associated components to facilitate precise imaging for diagnostic purposes. Its design aligns with regulatory standards for tomographic imaging, ensuring consistent and reliable performance in clinical radiology settings.
The Bennett X-Ray Tomography System is supplied as a complete imaging unit, intended for use in radiology departments or chiropractic clinics. It is a reusable device, requiring proper maintenance and calibration to ensure imaging accuracy and safety. The system is not classified as MRI-safe or MRI-conditional, and its operation adheres to FDA 510(k) clearance (K945749) under the Radiology advisory committee. Storage and handling follow standard radiologic equipment protocols to preserve functionality and compliance with regulatory requirements, including those outlined in 21 CFR 892.1740.
Other devices from Bennett X-Ray Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Bennett X-Ray Tomography System used for?
The Bennett X-Ray Tomography System is designed to produce detailed radiologic images of specific cross-sectional planes within the body. By selectively blurring or eliminating detail from adjacent planes, it enables precise visualization of targeted anatomical structures, making it particularly useful for diagnostic purposes in radiology departments and chiropractic clinics.
How is the Bennett X-Ray Tomography System supplied and maintained?
The system is supplied as a complete imaging unit, including signal analysis and display equipment, patient positioning supports, and associated components. It is a reusable device, requiring regular maintenance and calibration to ensure imaging accuracy and safety. Proper care aligns with standard radiologic equipment protocols to preserve functionality and compliance with regulatory standards.
Is the Bennett X-Ray Tomography System single-use or reusable?
The Bennett X-Ray Tomography System is a reusable device. Unlike single-use equipment, it is designed for repeated use in clinical settings, provided it undergoes proper maintenance, calibration, and adherence to regulatory guidelines to ensure consistent performance and safety.
What regulatory clearance does the Bennett X-Ray Tomography System hold?
The Bennett X-Ray Tomography System holds FDA 510(k) clearance under the Radiology advisory committee, with the clearance number K945749. This classification confirms its substantial equivalence to a predicate device and compliance with regulatory standards for tomographic imaging.
How should the Bennett X-Ray Tomography System be stored and handled?
Storage and handling of the Bennett X-Ray Tomography System follow standard protocols for radiologic equipment to maintain functionality and compliance. This includes proper environmental conditions, protection from physical damage, and adherence to guidelines outlined in 21 CFR 892.1740. Regular inspections and maintenance are recommended to ensure optimal performance.