Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K161563 |
Device Name |
Allura Xper FD series and Allura Xper OR Table series |
Applicant |
Philips Medical Systems Nederland BV |
VEENPLUIS 4-6 |
BEST,
NL
5684PC
|
|
Applicant Contact |
Jeanette Becker |
Correspondent |
Philips Medical Systems Nederland BV |
VEENPLUIS 4-6 |
BEST,
NL
5684PC
|
|
Correspondent Contact |
Jeanette Becker |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 06/06/2016 |
Decision Date | 07/29/2016 |
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
|