FOCUS RTP

System, Planning, Radiation Therapy Treatment

COMPUTERIZED MEDICAL SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK915691
510k NumberK915691
Device Name:FOCUS RTP
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant COMPUTERIZED MEDICAL SYSTEMS, INC. 56 WORTHINGTON DR. Maryland Heights,  MO  63043 -3806
ContactKim Ort
CorrespondentKim Ort
COMPUTERIZED MEDICAL SYSTEMS, INC. 56 WORTHINGTON DR. Maryland Heights,  MO  63043 -3806
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-23
Decision Date1995-02-16

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