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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 K913078
Device Name LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET
Applicant
Norland Corp.
W6340 Hackbarth Rd.
Fort Atkinson,  WI  53538
Applicant Contact W SCHWALENBERG
Correspondent
Norland Corp.
W6340 Hackbarth Rd.
Fort Atkinson,  WI  53538
Correspondent Contact W SCHWALENBERG
Regulation Number892.1170
Classification Product Code
KGI  
Date Received07/11/1991
Decision Date 09/24/1991
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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