Device Classification Name |
system, x-ray, fluoroscopic, image-intensified
|
510(k) Number |
K233945 |
Device Name |
ProxiDiagnost N90 / Precision CRF (706110, 706400) |
Applicant |
Philips Medical Systems DMC GmbH |
Roentgenstrasse 24 |
Hamburg,
DE
22335
|
|
Applicant Contact |
Ming Xiao |
Correspondent |
Philips Medical Systems DMC GmbH |
Roentgenstrasse 24 |
Hamburg,
DE
22335
|
|
Correspondent Contact |
Ming Xiao |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/14/2023 |
Decision Date | 01/11/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|