Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K133526 |
Device Name |
MDIXON-QUANT |
Applicant |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
595 MINER RD. |
CLEVLAND,
OH
44143
|
|
Applicant Contact |
SUSAN QUICK |
Correspondent |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
595 MINER RD. |
CLEVLAND,
OH
44143
|
|
Correspondent Contact |
SUSAN QUICK |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/15/2013 |
Decision Date | 02/12/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|