Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K113541 |
Device Name |
CLEARSTART SVM SYSTEM |
Applicant |
INTIO INC. |
325 INTERLOCKEN PARKWAY |
BROOMFIELD,
CO
80021
|
|
Applicant Contact |
DAVID GUSTAFSON |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/01/2011 |
Decision Date | 12/16/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|