Identifiers
- 510(k) Number
- K012313 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)
The CT Colonography Navigator2 is a computed tomography (CT) imaging system designed for virtual colonoscopy, enabling non-invasive visualization of the colon. It provides three-dimensional reconstruction and navigation capabilities to assess the mucosal surface and detect abnormalities such as polyps or tumors. This device supports diagnostic evaluation of the large intestine without the need for traditional endoscopic procedures.
The system is intended for use in radiology departments and requires integration with a CT scanner for imaging acquisition. Supplied as a software application, it is not sterile and is intended for single-use per patient examination. The device operates within standard MRI safety guidelines for non-MR conditional use, as it does not contain ferromagnetic materials. Authorized under FDA 510(k) clearance (K012313), it adheres to regulatory standards outlined in 21 CFR 892.1750.
Frequently asked questions
What is the CT Colonography Navigator2 used for?
The CT Colonography Navigator2 is a software application designed for virtual colonoscopy, allowing radiologists to visualize the colon’s mucosal surface in three dimensions without invasive endoscopic procedures. It helps detect abnormalities such as polyps or tumors by reconstructing CT scan data, enabling a comprehensive diagnostic evaluation of the large intestine.
How is the CT Colonography Navigator2 supplied and intended for use?
The device is supplied as a software application and is not sterile. It is intended for single-use per patient examination, meaning each installation should be dedicated to one diagnostic session. The software integrates with a CT scanner to acquire imaging data and perform 3D reconstruction and navigation.
Is the CT Colonography Navigator2 safe for use in MRI environments?
Yes, the CT Colonography Navigator2 is classified as non-MR conditional for use in MRI environments. This designation means it does not contain ferromagnetic materials and adheres to standard MRI safety guidelines, reducing the risk of interference or hazards in mixed radiology settings.
What regulatory clearance does the CT Colonography Navigator2 hold?
The CT Colonography Navigator2 holds FDA 510(k) clearance under the reference number K012313. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards outlined in 21 CFR 892.1750.
Can the CT Colonography Navigator2 be reused across multiple patients?
No, the CT Colonography Navigator2 is intended for single-use per patient examination. While the software itself may be installed on a system, each diagnostic session should be treated as a new instance to ensure patient-specific accuracy and hygiene standards, aligning with best practices for medical imaging software.
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: K012313 - CT COLONOGRAPHY/NAVIGATOR2 | FDA 510 (k), CT COLONOGRAPHY/NAVIGATOR2 (K012313) — FDA 510(k) | Innolitics, PDF K012313 - Ct Colonography/Navigator2, CT COLONOGRAPHY/NAVIGATOR2 510 (k) K012313 - FDA.report, CT COLONOGRAPHY (K023943) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012313 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ge Medical Systems, Inc.
Sources (1)
- FDA 510(k) K012313 24 fields · synced Oct 5, 2026