Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K143128 |
Device Name |
mDIXON XD |
Applicant |
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. |
VEENPLUIS 4-6 |
BEST,
NL
|
|
Applicant Contact |
JAN VAN DE KERKHOF |
Correspondent |
PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC |
595 MINER RD |
CLEVELAND,
OH
44094
|
|
Correspondent Contact |
SUSAN QUICK |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 10/30/2014 |
Decision Date | 03/20/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|