Device Classification Name |
image-intensified fluoroscopic x-ray system, mobile
|
510(k) Number |
K760429 |
Device Name |
FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS. |
Applicant |
VARIAN ASSOC., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
VARIAN ASSOC., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 08/13/1976 |
Decision Date | 08/23/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|