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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K905695
Device Name MICRO-X 80HF
Applicant
Fischer Imaging Corp.
12300 N. Grant St.
Denver,  CO  80241
Applicant Contact RICHARD S LUCAS
Correspondent
Fischer Imaging Corp.
12300 N. Grant St.
Denver,  CO  80241
Correspondent Contact RICHARD S LUCAS
Regulation Number892.1700
Classification Product Code
IZO  
Date Received12/19/1990
Decision Date 03/06/1991
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
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