Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K181479 |
Device Name |
Ingenia Ambition S and Ingenia Ambition X |
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. |
Miner Road 595 |
Cleveland,
OH
44143
|
|
Correspondent Contact |
Susan Quick |
Regulation Number | 892.1000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/05/2018 |
Decision Date | 08/03/2018 |
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
|
|
|