Device Classification Name |
system, x-ray, tomographic
|
510(k) Number |
K193262 |
Device Name |
DR 600 with Tomosynthesis |
Applicant |
Agfa N.V. |
Septestraat 27 |
Mortsel,
BE
B-2640
|
|
Applicant Contact |
Wim Govaerts |
Correspondent |
Agfa US Corp. |
10 South Academy Street |
Greenville,
SC
29601
|
|
Correspondent Contact |
ShaeAnn Cavanagh |
Regulation Number | 892.1740
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/26/2019 |
Decision Date | 03/09/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|