Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K032638 |
Device Name |
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY |
Applicant |
PLANAR SYSTEMS, INC. |
400 FIFTH AVENUE |
WALTHAM,
MA
02451
|
|
Applicant Contact |
SUSAN HAMANN |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/27/2003 |
Decision Date | 09/11/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|