Device Classification Name |
system, x-ray, stationary
|
510(k) Number |
K192541 |
Device Name |
DigiX FDX |
Applicant |
Allengers Medical Systems Limited |
Bhankharpur, Mubarakpur Road |
Derabassi, Distt Mohali,
IN
140507
|
|
Applicant Contact |
Sanjeev K. Marjara |
Correspondent |
Allengers Medical Systems Limited |
Bhankharpur, Mubarakpur Road |
Derabassi, Distt Mohali,
IN
140507
|
|
Correspondent Contact |
Sanjeev K. Marjara |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 09/16/2019 |
Decision Date | 10/16/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|