Tomographic Scanner, Computerized
510(k) K772125
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK772125 | Date21 Nov 1977 | 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- Withdrawn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 Tomographic Scanner, Computerized is a medical imaging device classified as a Computed Tomography (CT) Scanner, designed to produce detailed cross-sectional images of the body using X-rays. It enables high-resolution visualization of internal structures, facilitating diagnostic evaluations in radiology, cardiology, oncology, and trauma care. By reconstructing multiple X-ray projections into transverse slices, it provides comprehensive anatomical details for clinical assessment. This technology represents a significant advancement over conventional radiography by offering three-dimensional imaging capabilities.
This device is intended for use in hospital and outpatient radiology settings, where it supports fast, high-volume diagnostic imaging. Supplied as a reusable medical instrument, it requires proper maintenance and calibration to ensure accurate imaging performance. The scanner operates within standard radiology environments and is not classified as MRI-safe or MRI-conditional. Authorized for use in the United States under FDA 510(k) clearance (K772125), it adheres to regulatory standards for radiologic imaging devices. Storage and handling follow standard protocols for medical imaging equipment to preserve functionality and ensure patient safety.
Other devices from Emi Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What clinical specialties benefit most from this tomographic scanner’s imaging capabilities?
This scanner is particularly valuable in radiology for detailed anatomical assessments, cardiology for heart and vascular evaluations, oncology for tumor visualization, and trauma care for injury analysis. Its ability to reconstruct X-ray projections into transverse slices provides three-dimensional anatomical details, enabling precise diagnostic evaluations across these specialties.
How is this device supplied and what maintenance is required?
The Emi Computerized Tomographic Scanner is supplied as a reusable medical instrument, meaning it is designed for repeated use in clinical settings. To maintain accurate imaging performance, it requires regular maintenance and calibration as specified by the manufacturer’s guidelines. Proper upkeep ensures consistent image quality and reliability for diagnostic purposes.
Is this scanner suitable for MRI environments, or does it pose any risks?
This device is not classified as MRI-safe or MRI-conditional. It operates using X-rays and is intended for use exclusively in standard radiology environments. Placing it in an MRI setting could pose risks to both the device and patients, so it must only be used in non-MRI areas.
What storage and handling protocols should be followed for this scanner?
Storage and handling of the Emi Computerized Tomographic Scanner follow standard protocols for medical imaging equipment. It should be stored in a clean, dry environment protected from physical damage, extreme temperatures, and electromagnetic interference. Proper storage ensures the device’s functionality and longevity while maintaining patient safety during use.
What distinguishes this scanner from conventional radiography?
Unlike conventional radiography, which produces two-dimensional images, this scanner generates detailed cross-sectional and three-dimensional images by reconstructing multiple X-ray projections. This advancement allows for more precise visualization of internal structures, improving diagnostic accuracy in complex cases.