Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K161130 |
Device Name |
ResolutionMD |
Applicant |
CALGARY SCIENTIFIC, INC. |
SUITE 208, 1210- 20TH AVENUE SE |
CALGARY,
CA
T2G 1M8
|
|
Applicant Contact |
Kyle Peterson |
Correspondent |
CALGARY SCIENTIFIC, INC. |
SUITE 208, 1210- 20TH AVENUE SE |
CALGARY,
CA
T2G 1M8
|
|
Correspondent Contact |
Kyle Peterson |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 04/21/2016 |
Decision Date | 08/24/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|