Device Classification Name |
system, x-ray, fluoroscopic, image-intensified
|
510(k) Number |
K810716 |
Device Name |
X-RAY IMAGE INTENSIFIER PRODUCTS |
Applicant |
INSTRUMENTATION CAMERA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
INSTRUMENTATION CAMERA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 03/17/1981 |
Decision Date | 04/23/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|