Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K162931 |
Device Name |
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 |
Applicant |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
VEENPLUIS 4-6 |
BEST,
NL
5684 PC
|
|
Applicant Contact |
Ruojuan Zhang |
Correspondent |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
VEENPLUIS 4-6 |
BEST,
NL
5684 PC
|
|
Correspondent Contact |
Ruojuan Zhang |
Regulation Number | 892.1000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/19/2016 |
Decision Date | 01/06/2017 |
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
|
|
|