NWE
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Colon Computed Tomography System, Computer Aided Detection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Medical specialty
- Radiology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SYNGO.CT COLONOGRAPHY (K140920) | Siemens Medical Solutions USA, Inc. | 2014-12-03 |
| COLONCAD API 3.1 (K083423) | Medicsight Plc | 2011-05-17 |
| COLON CAR 1.2 (K042674) | Medicsight | 2004-10-19 |
| COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY (K042605) | Siemens AG Medical Solutions | 2004-10-08 |
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Every clearance here is in the API, with alerts when new ones post.