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Computerized Axial Tomography System

by Emi Medical, Inc.

510(k) K780995

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK780995 Date22 Jun 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Computerized Axial Tomography
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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Computerized Axial Tomography System is an X-Ray, Tomographic System designed for generating cross-sectional images of the body. It utilizes computed tomography to produce detailed axial slices, enabling comprehensive visualization of internal anatomical structures in multiple planes. This technology allows radiologists to reconstruct three-dimensional images, improving diagnostic accuracy for complex regions. The system is primarily used in radiology departments for enhanced assessment of internal anatomy compared to traditional imaging methods.

The device is intended for use in radiology settings and may incorporate contrast agents such as Hypaque 60% (100 cc) for vascular imaging. It holds FDA 510(k) clearance (K780995) and is classified under regulation number 892.1740 as a Class II medical device. No specific details regarding MRI safety, sterility, or storage conditions are provided in the available data. The system is not designated as single-use or reusable in the specifications.

Computerized Axial Tomography System

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