SOMATOM X.cite
System, X-ray, Tomography, Computed
Siemens Medical Solutions USA, Inc.
The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom X.cite.
Pre-market Notification Details
| Device ID | K191891 |
| 510k Number | K191891 |
| Device Name: | SOMATOM X.cite |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Contact | Tabitha Estes |
| Correspondent | Tabitha Estes Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-15 |
| Decision Date | 2019-11-06 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869231044 | K191891 | 000 |
Trademark Results [SOMATOM X.cite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOMATOM X.CITE 79279927 not registered Live/Pending |
Siemens Healthcare GmbH 2020-01-15 |
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