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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomographic, Nuclear
510(k) Number K914350
Device Name ICON COMPUTER SYSTEM
Applicant
Siemens Gammasonics, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195 -7372
Applicant Contact IRENA KRUTULIS
Correspondent
Siemens Gammasonics, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195 -7372
Correspondent Contact IRENA KRUTULIS
Regulation Number892.1310
Classification Product Code
JWM  
Date Received09/27/1991
Decision Date 11/22/1991
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
Recalls CDRH Recalls
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