Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K170113 |
Device Name |
pixium 4343RCE |
Applicant |
Philips Medical Systems DMC GmbH |
Roentgenstrasse 24-26 |
Hamburg,
DE
22335
|
|
Applicant Contact |
Ming Xiao |
Correspondent |
Philips Medical Systems DMC GmbH |
Roentgenstrasse 24-26 |
Hamburg,
DE
22335
|
|
Correspondent Contact |
Ming Xiao |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 01/12/2017 |
Decision Date | 02/09/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|