Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K761332 |
Device Name |
HI-SENSITIVITY MODE OPTION FOR S60-1A |
Applicant |
SYNTEX CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SYNTEX CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 12/27/1976 |
Decision Date | 12/30/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|