Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K183548 |
Device Name |
SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 |
Applicant |
Siemens Medical Solutions USA, Inc. |
40 Liberty Blvd. |
Malvern,
PA
19355
|
|
Applicant Contact |
Kimberly Mangum |
Correspondent |
Siemens Medical Solutions USA, Inc. |
40 Liberty Blvd. |
Malvern,
PA
19355
|
|
Correspondent Contact |
Kimberly Rendon |
Regulation Number | 892.1750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/20/2018 |
Decision Date | 04/15/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|