Identifiers
- 510(k) Number
- K023943 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ct Colonography is a medical imaging system designed to perform computed tomography examinations of the colon. This device utilizes imaging techniques to assist in the diagnostic evaluation of the colon.
This device has received FDA 510(k) clearance. It is manufactured by GE Medical Systems, Inc. and is categorized under the radiology advisory committee.
Frequently asked questions
What is the primary function of the CT Colonography system?
This device is a computed tomography imaging system specifically engineered to perform examinations of the colon. It utilizes advanced imaging techniques to support clinicians in the diagnostic evaluation of the colon.
Who is the manufacturer of this imaging device?
The CT Colonography system is manufactured by GE Medical Systems, Inc., which is based in Milwaukee, Wisconsin.
What is the regulatory status of this device?
The CT Colonography system has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K023943 FDA 510(k) - CT COLONOGRAPHY | Ge Medical Systems, Inc., Ct Colonography 510 (k) FDA Premarket Notification K023943 GE MEDICAL ..., GE CT Colonography II - allmed.wiki, CT Colonography Systems Market Size and Forecast Report 2026-2030, GE gets clearance for CT colonography | AuntMinnie
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023943 | Class II | Active |
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Manufacturer
- Manufacturer
- Ge Medical Systems, Inc.
Sources (1)
- FDA 510(k) K023943 24 fields · synced Oct 6, 2026