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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K924240
Device Name PROWESS 2000
Applicant
Small Systems Group, Inc.
15 Quadra Ct.
Chico,  CA  95928
Applicant Contact PHILIP H HEINTZ
Correspondent
Small Systems Group, Inc.
15 Quadra Ct.
Chico,  CA  95928
Correspondent Contact PHILIP H HEINTZ
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/24/1992
Decision Date 05/17/1993
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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