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CT/T Independent Diagnostic Center

by General Electric Co.

510(k) K780480

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 NumberK780480 Date18 Apr 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  • Withdrawn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)

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, 22 Sep 2026

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

The CT/T Independent Diagnostic Center is a System, X-ray, Tomography, Computed device used in radiology. It is a Class II CT scanner manufactured by General Electric Co.

The device is supplied by General Electric Co. in Mchenry, US. It received FDA 510(k) clearance on April 18, 1978 under K-number K780480 with product code JAK.

Other devices from General Electric Co.

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Questions

AI-generated answers, 22 Sep 2026

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

  • What is the CT/T Independent Diagnostic Center used for?

    The CT/T Independent Diagnostic Center is a System, X-ray, Tomography, Computed device used in radiology for diagnostic imaging purposes. It is a Class II CT scanner manufactured by General Electric Co.

  • How is the CT/T Independent Diagnostic Center supplied?

    The device is supplied by General Electric Co. from their location at 803 N. Front St. Suite 3, Mchenry, IL 60050, US.

  • What is the regulatory status of the CT/T Independent Diagnostic Center?

    The CT/T Independent Diagnostic Center received FDA 510(k) clearance on April 18, 1978 under K-number K780480 with product code JAK. It was determined to be substantially equivalent to predicate devices.

  • What advisory committee reviewed the CT/T Independent Diagnostic Center?

    The device was reviewed by the Radiology Advisory Committee (RA), which provides expert advice to the FDA on radiology devices and their safety and effectiveness.