FOCUS PILOT CONTOURING WORKSTATION

Accelerator, Linear, Medical

COMPUTERIZED MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Focus Pilot Contouring Workstation.

Pre-market Notification Details

Device IDK981535
510k NumberK981535
Device Name:FOCUS PILOT CONTOURING WORKSTATION
ClassificationAccelerator, Linear, Medical
Applicant COMPUTERIZED MEDICAL SYSTEMS, INC. 1195 CORPORATE LAKE DR. St. Louis,  MO  63132 -1716
ContactMichael A Parsons
CorrespondentMichael A Parsons
COMPUTERIZED MEDICAL SYSTEMS, INC. 1195 CORPORATE LAKE DR. St. Louis,  MO  63132 -1716
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-29
Decision Date1999-04-02
Summary:summary

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