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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K933446
Device Name PICTURE ARCHIVING & COMMUNICATIONS SYSTEMS(PACS)
Applicant
Sudbury Systems, Inc.
490 Boston Post Rd.
Sudbury,  MA  01776
Applicant Contact PAUL A NYSTROM
Correspondent
Sudbury Systems, Inc.
490 Boston Post Rd.
Sudbury,  MA  01776
Correspondent Contact PAUL A NYSTROM
Regulation Number892.1200
Classification Product Code
KPS  
Date Received07/13/1993
Decision Date 11/01/1993
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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