Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K020995 |
Device Name |
EFILM WORKSTATION WITH MODULES |
Applicant |
EFILM MEDICAL, INC. |
500 UNIVERSITY AVE., SUITE 300 |
TORONTO, ONTARIO,
CA
M5G 1V7
|
|
Applicant Contact |
JOSEPH A THOMAS |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
NEIL E DEVINE |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/28/2002 |
Decision Date | 04/12/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|