Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K190461 |
Device Name |
Achieva 1.5T, 3.0T and Intera 1.5T MR Systems |
Applicant |
Philips Medical Systems Nederland B.V. |
Veenpluis 4-6 |
Best,
NL
5684 PC
|
|
Applicant Contact |
Jan van de Kerkhof |
Correspondent |
Philips Medical Systems Nederland B.V. |
595 Miner Road |
Cleveland,
OH
44143
|
|
Correspondent Contact |
Susan Quick |
Regulation Number | 892.1000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/26/2019 |
Decision Date | 06/04/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|