Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K964626 |
Device Name |
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE |
Applicant |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
5500 AVION PARK DR. |
HIGHLAND HEIGHTS,
OH
44143
|
|
Applicant Contact |
ELAINE K KEELER |
Correspondent |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
5500 AVION PARK DR. |
HIGHLAND HEIGHTS,
OH
44143
|
|
Correspondent Contact |
ELAINE K KEELER |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/19/1996 |
Decision Date | 02/10/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|