Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K130638 |
Device Name |
ALLURACLARITY XPER FD SERIES X-RAY SYSTEM |
Applicant |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
VEENPLUIS 4-6 |
BEST,
NL
5694 PC
|
|
Applicant Contact |
KLIEN VAN DAM |
Correspondent |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
VEENPLUIS 4-6 |
BEST,
NL
5694 PC
|
|
Correspondent Contact |
KLIEN VAN DAM |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 03/11/2013 |
Decision Date | 06/28/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|