Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K181830 |
Device Name |
Azurion R2.0 |
Applicant |
Philips Medical Systems Nederland BV |
Veenpluis 4-6 |
Best,
NL
5684PC
|
|
Applicant Contact |
Owen Callaghan |
Correspondent |
Philips Medical Systems Nederland BV |
Veenpluis 4-6 |
Best,
NL
5684PC
|
|
Correspondent Contact |
Owen Callaghan |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/09/2018 |
Decision Date | 08/02/2018 |
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
|
|
|