Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K102344 |
Device Name |
MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS |
Applicant |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
22100 BOTHELL EVERETT HIGHWAY |
BOTHELL,
WA
98041 -8431
|
|
Applicant Contact |
LYNN HARMER |
Correspondent |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
22100 BOTHELL EVERETT HIGHWAY |
BOTHELL,
WA
98041 -8431
|
|
Correspondent Contact |
LYNN HARMER |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 08/18/2010 |
Decision Date | 11/09/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|