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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, Tomography, Computed
510(k) Number K891931
Device Name QCT-LUNG NODULE (TM) ANALYSIS PACKAGE
Applicant
Image Analysis, Inc.
17935 - F Skypark Cir.
Irvine,  CA  92714
Applicant Contact ARNOLD, PH.D.
Correspondent
Image Analysis, Inc.
17935 - F Skypark Cir.
Irvine,  CA  92714
Correspondent Contact ARNOLD, PH.D.
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/28/1989
Decision Date 05/18/1989
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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