Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K111346 |
FOIA Releasable 510(k) |
K111346
|
Device Name |
RESOLUTIONMD MOBILE MODEL RMB-MOB-2X |
Applicant |
CALGARY SCIENTIFIC, INC. |
SUITE 208, 1210 20TH AVENUE SE |
CALGARY, ALBERTA,
CA
T2G 1M8
|
|
Applicant Contact |
KYLE PETERSON |
Correspondent |
CALGARY SCIENTIFIC, INC. |
SUITE 208, 1210 20TH AVENUE SE |
CALGARY, ALBERTA,
CA
T2G 1M8
|
|
Correspondent Contact |
KYLE PETERSON |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/13/2011 |
Decision Date | 09/09/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|