The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Force, Somatom Definition Flash, Somatom Drive, Somatom Definition Edge, Somatom Definition As Open, Somatom Deinition As/as+, Somatom Confidence.
| Device ID | K173630 |
| 510k Number | K173630 |
| Device Name: | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. Malvern, PA 19355 |
| Contact | Kimberly Mangum |
| Correspondent | Kimberly Mangum Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. 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 | 2017-11-24 |
| Decision Date | 2018-03-30 |
| Summary: | summary |