The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo.ct Extended Functionality.
| Device ID | K163341 |
| 510k Number | K163341 |
| Device Name: | Syngo.CT Extended Functionality |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, Inc. 40 Liberty Blvd., Mail Code 65-1A Malvern, PA 19355 |
| Contact | Kimberly Mangum |
| Correspondent | Kimberly Mangum SIEMENS MEDICAL SOLUTIONS USA, Inc. 40 Liberty Blvd., Mail Code 65-1A Malvern, PA 19355 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-29 |
| Decision Date | 2017-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869026497 | K163341 | 000 |