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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 K934868
Device Name LORAD TRANSPO
Applicant
Lorad Corp.
36 Apple Ridge Rd.
Danbury,  CT  06810
Applicant Contact PHILIP JUHAS
Correspondent
Lorad Corp.
36 Apple Ridge Rd.
Danbury,  CT  06810
Correspondent Contact PHILIP JUHAS
Regulation Number892.1710
Classification Product Code
IZH  
Date Received10/12/1993
Decision Date 10/14/1994
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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