The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo.ct Colonography.
| Device ID | K140920 |
| 510k Number | K140920 |
| Device Name: | SYNGO.CT COLONOGRAPHY |
| Classification | Colon Computed Tomography System, Computer Aided Detection |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY Malven, PA 19355 |
| Contact | Kimberly Mangum |
| Correspondent | Kimberly Mangum SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY Malven, PA 19355 |
| Product Code | NWE |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-10 |
| Decision Date | 2014-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869026367 | K140920 | 000 |
| 04056869013893 | K140920 | 000 |
| 04056869007809 | K140920 | 000 |