MAMMOPATH


Device Classification Name

cabinet,x-ray system

510(k) Number K021113
Device Name MAMMOPATH
Original Applicant
FISCHER IMAGING CORP.
12300 north grant st.
denver, 
CO 
80241 -3120

Original Contact samir b paliwal
Regulation Number 892.1680
Classification Product Code
MWP  
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