XIO RTP SYSTEM

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 Xio Rtp System.

Pre-market Notification Details

Device IDK102216
510k NumberK102216
Device Name:XIO RTP SYSTEM
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant COMPUTERIZED MEDICAL SYSTEMS, INC. 13723 RIVERPORT DR SUITE 100 Maryland Heights,  MO  63043
ContactKathryn Stinson
CorrespondentKathryn Stinson
COMPUTERIZED MEDICAL SYSTEMS, INC. 13723 RIVERPORT DR SUITE 100 Maryland Heights,  MO  63043
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-06
Decision Date2010-10-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858164002114 K102216 000

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