Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K141979 |
Device Name |
ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES |
Applicant |
PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V. |
VEENPLUIS 4-6 |
5684-PC |
BEST,
NL
NETHERLAND
|
|
Applicant Contact |
JEANETTE BECKER |
Correspondent |
PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V. |
VEENPLUIS 4-6 |
5684-PC |
BEST,
NL
NETHERLAND
|
|
Correspondent Contact |
JEANETTE BECKER |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/21/2014 |
Decision Date | 08/19/2014 |
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
|
|
|