Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K231560 |
Device Name |
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit |
Applicant |
Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard |
Malvern,
PA
19355
|
|
Applicant Contact |
Alina Goodman |
Correspondent |
Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard |
Malvern,
PA
19355
|
|
Correspondent Contact |
Alina Goodman |
Regulation Number | 892.1000
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/30/2023 |
Decision Date | 10/23/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|