Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K112974 |
Device Name |
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
Applicant |
CURVE DENTAL, INC. |
424 W. 800 N. SUITE 202 |
OREM,
UT
84057
|
|
Applicant Contact |
GEORGE STANTCHEV |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1285 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
CASEY CONRY |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 10/05/2011 |
Decision Date | 10/20/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|