Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K032036 |
Device Name |
GEMINI 16 |
Applicant |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
595 MINER RD. |
CLEVELAND,
OH
44143
|
|
Applicant Contact |
CHRISTOF LITTWITZ |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
HEINZ J STENEBERG |
Regulation Number | 892.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/01/2003 |
Decision Date | 07/11/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|