Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K884669 |
Device Name |
EXEL 2002 & 2002FS CT SCANNER |
Applicant |
ELSCINT, INC. |
930 COMMONWEALTH AVE. |
BOSTON,
MA
02215
|
|
Applicant Contact |
SOBEL |
Correspondent |
ELSCINT, INC. |
930 COMMONWEALTH AVE. |
BOSTON,
MA
02215
|
|
Correspondent Contact |
SOBEL |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 11/08/1988 |
Decision Date | 12/30/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|