Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K010336 |
Device Name |
ADVANTAGE WINDOWS CT/PET FUSION |
Applicant |
GE MEDICAL SYSTEMS, INC. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
LARRY A KROGER |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
REINER KRUMME |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 02/05/2001 |
Decision Date | 02/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|