Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K133657 |
Device Name |
DISCOVERY PET/CT 710 |
Applicant |
GE MEDICAL SYSTEMS, LLC |
3000 N GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
DAVID DUERSTELER |
Correspondent |
GE MEDICAL SYSTEMS, LLC |
3000 N GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
DAVID DUERSTELER |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 11/27/2013 |
Decision Date | 03/21/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|