Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K141881 |
Device Name |
RAPIDRESULTS |
Applicant |
RAMSOFT, INC. |
243 COLLEGE ST.,SUITE 100 |
toronto, on,
CA
m5t 1r5
|
|
Applicant Contact |
lely lam-hong |
Correspondent |
RAMSOFT, INC. |
243 COLLEGE ST.,SUITE 100 |
toronto, on,
CA
m5t 1r5
|
|
Correspondent Contact |
lely lam-hong |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/11/2014 |
Decision Date | 10/31/2014 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|