Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K121517 |
Device Name |
VERSAVUE ENTERPRISE SUITE |
Applicant |
ICAD, INC. |
98 SPIT BROOK ROAD |
SUITE 100 |
NASHUA,
NH
03062
|
|
Applicant Contact |
MICHAEL A PATZ |
Correspondent |
ICAD, INC. |
98 SPIT BROOK ROAD |
SUITE 100 |
NASHUA,
NH
03062
|
|
Correspondent Contact |
MICHAEL A PATZ |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/22/2012 |
Decision Date | 07/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|