Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K161567 |
Device Name |
SIGNA Voyager |
Applicant |
GE HEALTHCARE |
3200 N. GRANDVIEW BLVD |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
Glen Sabin |
Correspondent |
GE HEALTHCARE |
3200 N. GRANDVIEW BLVD |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
Glen Sabin |
Regulation Number | 892.1000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/07/2016 |
Decision Date | 09/01/2016 |
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
|
|
|