The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Emotion 6/16.
| Device ID | K151752 |
| 510k Number | K151752 |
| Device Name: | SOMATOM Emotion 6/16 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 |
| Contact | Eve Davis |
| Correspondent | John Urtz 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-29 |
| Decision Date | 2015-11-12 |
| Summary: | summary |