SOMATOM DEFINITION EDGE
System, X-ray, Tomography, Computed
SIEMENS MEDICAL SYSTEMS, INC.
The following data is part of a premarket notification filed by Siemens Medical Systems, Inc. with the FDA for Somatom Definition Edge.
Pre-market Notification Details
| Device ID | K120579 |
| 510k Number | K120579 |
| Device Name: | SOMATOM DEFINITION EDGE |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406 |
| Contact | Kimberly Mangum |
| Correspondent | Kimberly Mangum SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-27 |
| Decision Date | 2012-05-23 |
Trademark Results [SOMATOM DEFINITION EDGE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOMATOM DEFINITION EDGE 79104821 4181439 Live/Registered |
Siemens Healthcare GmbH 2011-09-21 |
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