Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K063031 |
Device Name |
PRISM VIEW, MODEL |
Applicant |
KYRON CLINICAL IMAGING, INC. |
2457 N. MAYFAIR RD., SUITE 202 |
WAUWATOSA,
WI
53226
|
|
Applicant Contact |
JAMES L REUSS, PH.D. |
Correspondent |
KYRON CLINICAL IMAGING, INC. |
2457 N. MAYFAIR RD., SUITE 202 |
WAUWATOSA,
WI
53226
|
|
Correspondent Contact |
JAMES L REUSS, PH.D. |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 10/03/2006 |
Decision Date | 11/02/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|