Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K081426 |
Device Name |
NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE |
Applicant |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
595 MINER RD. |
CLEVELAND,
OH
44143
|
|
Applicant Contact |
MELINDA NOVATNY |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
JEFF D RONGERO |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 05/21/2008 |
Decision Date | 06/04/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|