Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K071436 |
Device Name |
REGIUS UNITEA |
Applicant |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
140 EAST 45TH ST., 25TH FLOOR |
TWO GRAND CENTRAL TOWER |
NEW YORK,
NY
10017
|
|
Applicant Contact |
RUSSELL MUNVES |
Correspondent |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
140 EAST 45TH ST., 25TH FLOOR |
TWO GRAND CENTRAL TOWER |
NEW YORK,
NY
10017
|
|
Correspondent Contact |
RUSSELL MUNVES |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/23/2007 |
Decision Date | 06/27/2007 |
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
|
|
|