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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K926571
Device Name MRINNERVU(R) ENDORECTAL PROSTATE COIL BPX-15
Applicant
Medrad, Inc.
Kappa Manor Ii
271 Kappa Dr.
Pittsburgh,  PA  15238
Applicant Contact JOHN E STEVENS
Correspondent
Medrad, Inc.
Kappa Manor Ii
271 Kappa Dr.
Pittsburgh,  PA  15238
Correspondent Contact JOHN E STEVENS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/31/1992
Decision Date 07/20/1993
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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