CT/T Independent Diagnostic Center
510(k) K780480
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780480 | Date18 Apr 1978 | 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- Withdrawn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, 22 Sep 2026
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.
Questions
AI-generated answers, 22 Sep 2026
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.