Device Classification Name |
system, x-ray, stationary
|
510(k) Number |
K163410 |
Device Name |
DigitalDiagnost C50 |
Applicant |
PHILIPS HEALTHCARE (SUZHOU) CO., LTD. |
NO. 258, ZHONG YUAN ROAD |
SUZHOU INDUSTRIAL PARK |
SUZHOU,
CN
215024
|
|
Applicant Contact |
ALINA ZHOU |
Correspondent |
PHILIPS HEALTHCARE (SUZHOU) CO., LTD. |
NO. 258, ZHONG YUAN ROAD |
SUZHOU INDUSTRIAL PARK |
SUZHOU,
CN
215024
|
|
Correspondent Contact |
ALINA ZHOU |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 12/05/2016 |
Decision Date | 01/04/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|