The following data is part of a premarket notification filed by Siemens Medical Systems, Inc. with the FDA for Syngo Single Source Dual Engery.
| Device ID | K122909 |
| 510k Number | K122909 |
| Device Name: | SYNGO SINGLE SOURCE DUAL ENGERY |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406 |
| Contact | Kimberly Mangum |
| Correspondent | Kimberly Mangum SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-21 |
| Decision Date | 2012-12-27 |
| Summary: | summary |