Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K090223 |
Device Name |
ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 |
Applicant |
ICAD, INC. |
98 SPIT BROOK ROAD |
SUITE 100 |
NASHUA,
NH
03062
|
|
Applicant Contact |
JOHN A DELUCIA |
Correspondent |
ICAD, INC. |
98 SPIT BROOK ROAD |
SUITE 100 |
NASHUA,
NH
03062
|
|
Correspondent Contact |
JOHN A DELUCIA |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 01/30/2009 |
Decision Date | 03/31/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|