Colon Computed Tomography System, Computer Aided Detection
The Computer-Aided Detection Colon CT System is a radiology software device designed to assist radiologists in the review of multi-slice computed tomography (MSCT) examinations of the colon by highlighting potential polyps that the radiologist should review, serving as a second reader in virtual colonoscopy interpretation. It is an FDA Class 2 device regulated under 21 CFR 892.2050 in the Radiology specialty, with product code NWE, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NWE
- Device Class
- FDA class 2
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Definition
To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140920 | SYNGO.CT COLONOGRAPHY | Dec 03, 2014 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K083423 | COLONCAD API 3.1 | May 17, 2011 | Substantially Equivalent | Medicsight Plc |
| K042674 | COLON CAR 1.2 | Oct 19, 2004 | Substantially Equivalent | Medicsight |
| K042605 | COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | Oct 08, 2004 | Substantially Equivalent | Siemens AG Medical Solutions |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.