Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K223009 |
Device Name |
Wireless/Wired X-Ray Flat Panel Detectors |
Applicant |
Allengers Medical Systems Limited |
FDA Hall Unit-2, Bhankarpur, Mubarakpur Road |
Derabassi, Distt. Mohali,
IN
140507
|
|
Applicant Contact |
Sanjeev K. Marjara |
Correspondent |
Allengers Medical Systems Limited |
FDA Hall Unit-2, Bhankarpur, Mubarakpur Road |
Derabassi, Distt. Mohali,
IN
140507
|
|
Correspondent Contact |
Sanjeev K. Marjara |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 09/29/2022 |
Decision Date | 11/27/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|