Device Classification Name |
interventional fluoroscopic x-ray system
|
510(k) Number |
K161839 |
Device Name |
2D Quantitative Analysis |
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 |
|
Subsequent Product Code |
|
Date Received | 07/05/2016 |
Decision Date | 07/29/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|