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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometer, Bone
510(k) Number K984178
Device Name PRONOSCO X-POSURE SYSTEM
Applicant
Torsana Osteoporosis Diagnostics A/S
555 13th St., NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN, ESQ
Correspondent
Torsana Osteoporosis Diagnostics A/S
555 13th St., NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN, ESQ
Regulation Number892.1170
Classification Product Code
KGI  
Date Received11/20/1998
Decision Date 02/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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