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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K861692
Device Name FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM
Applicant
Fischer Imaging Corp.
1800 Elmhurst Rd.
Elk Grove Village,  IL  60007
Applicant Contact NORVAL NORTHCOTT
Correspondent
Fischer Imaging Corp.
1800 Elmhurst Rd.
Elk Grove Village,  IL  60007
Correspondent Contact NORVAL NORTHCOTT
Regulation Number892.1710
Classification Product Code
IZH  
Date Received05/02/1986
Decision Date 12/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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