Device Classification Name |
system, x-ray, stationary
|
510(k) Number |
K193360 |
Device Name |
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard |
Applicant |
Radmedix LLC |
2510 Lance Dr. |
Dayton,
OH
45409
|
|
Applicant Contact |
Gabriel Issa |
Correspondent |
Kamm & Associates |
8870 Ravello Ct |
Naples,
FL
34114
|
|
Correspondent Contact |
Daniel Kamm |
Regulation Number | 892.1680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/04/2019 |
Decision Date | 01/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|