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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K010763
Device Name GOODNET
Applicant
Goodman Co., Ltd.
109 Danbury Rd.
Ridgefield,  CT  06877
Applicant Contact DOUGLAS F ORR
Correspondent
Goodman Co., Ltd.
109 Danbury Rd.
Ridgefield,  CT  06877
Correspondent Contact DOUGLAS F ORR
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/14/2001
Decision Date 05/25/2001
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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