SOMATOM Edge Plus
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 Edge Plus.
Pre-market Notification Details
| Device ID | K173607 |
| 510k Number | K173607 |
| Device Name: | SOMATOM Edge Plus |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 |
| Contact | Alaine Medio |
| Correspondent | Alaine Medio Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37934 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-21 |
| Decision Date | 2018-03-21 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869152684 | K173607 | 000 |
Trademark Results [SOMATOM Edge Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOMATOM EDGE PLUS 79227199 5582989 Live/Registered |
Siemens Healthcare GmbH 2017-12-21 |
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