SOMATOM DEFINITION AS
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 Definition As.
Pre-market Notification Details
| Device ID | K103127 |
| 510k Number | K103127 |
| Device Name: | SOMATOM DEFINITION AS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406 |
| Contact | Alicia Bustos-juergensen |
| Correspondent | Alicia Bustos-juergensen SIEMENS MEDICAL SOLUTIONS USA INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-22 |
| Decision Date | 2011-03-04 |
| Summary: | summary |
Trademark Results [SOMATOM DEFINITION AS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOMATOM DEFINITION AS 79052012 3612626 Live/Registered |
Siemens Healthcare GmbH 2008-02-27 |
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