Delivery Analysis

System, Planning, Radiation Therapy Treatment

ACCURAY INCORPORATED

The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Delivery Analysis.

Pre-market Notification Details

Device IDK143269
510k NumberK143269
Device Name:Delivery Analysis
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant ACCURAY INCORPORATED 1209 DEMING WAY Madison,  WI  53717
ContactKeith Picker
CorrespondentKeith Picker
ACCURAY INCORPORATED 1209 DEMING WAY Madison,  WI  53717
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-13
Decision Date2015-04-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M65810622130 K143269 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.