Device Classification Name |
cabinet,x-ray system |
|||
---|---|---|---|---|
510(k) Number | K021113 | |||
Device Name | MAMMOPATH | |||
Original Applicant |
|
|||
Original Contact | samir b paliwal | |||
Regulation Number | 892.1680 | |||
Classification Product Code |
|
|||
Date Received | 04/05/2002 | |||
Decision Date | 06/13/2002 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Radiology |
|||
510k Review Panel |
Radiology |
|||
statement |
statement |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |