Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K080927 |
Device Name |
BRIGHTVIEW VCT IMAGING SYSTEM |
Applicant |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
540 ALDER DRIVE |
MILPITAS,
CA
95035
|
|
Applicant Contact |
COLEEN A COLEMAN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
455 E. TRIMBLE ROAD |
SAN JOSE,
CA
95131 -1230
|
|
Correspondent Contact |
MORTEN CHRISTENSEN |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 04/02/2008 |
Decision Date | 04/11/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|