K140920 is an FDA 510(k) clearance for the SYNGO.CT COLONOGRAPHY. This device is classified as a Colon Computed Tomography System, Computer Aided Detection (Class II - Special Controls, product code NWE).
Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on December 3, 2014, 237 days after receiving the submission on April 10, 2014.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050. 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) Number | K140920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2014 |
| Decision Date | December 03, 2014 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | NWE — Colon Computed Tomography System, Computer Aided Detection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |
| 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. |