Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K131773 |
Device Name |
BRILLIANCE ICT |
Applicant |
PHILIPS HEALTHCARE (CLEVELAND) |
595 MINER RD. |
CLEVELAND,
OH
44143
|
|
Applicant Contact |
CATHERINE M CONNELL |
Correspondent |
PHILIPS HEALTHCARE (CLEVELAND) |
595 MINER RD. |
CLEVELAND,
OH
44143
|
|
Correspondent Contact |
CATHERINE M CONNELL |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 06/17/2013 |
Decision Date | 09/24/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|