Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K213516 |
Device Name |
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei |
Applicant |
Philips Medical Systems Nederland, B.V. |
Veenpluis 4-6 |
Best,
NL
5684PC
|
|
Applicant Contact |
Jan van de Kerkhof |
Correspondent |
Philips Medical Systems Nederland, B.V. |
Veenpluis 4-6 |
Best,
NL
5684PC
|
|
Correspondent Contact |
Jan van de Kerkhof |
Regulation Number | 892.1000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/03/2021 |
Decision Date | 03/03/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|