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 Edge Plus, Somatom Definition As/as+, Somatom Confidence.
| Device ID | K190578 |
| 510k Number | K190578 |
| Device Name: | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition 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 | Maria Ebio 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 | 2019-03-06 |
| Decision Date | 2019-06-27 |