The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Definition As Open (va48).
| Device ID | K143409 |
| 510k Number | K143409 |
| Device Name: | SOMATOM Definition AS Open (VA48) |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Solutions USA, Inc. 51 Valley Sstream Parkway Malvern, PA 19355 |
| Contact | Eve Davis |
| Correspondent | Eve Davis Siemens Medical Solutions USA, Inc. 51 Valley Sstream Parkway 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 | 2014-11-28 |
| Decision Date | 2015-03-26 |
| Summary: | summary |