GATECT-RT

Accelerator, Linear, Medical

VISION RT LIMITED

The following data is part of a premarket notification filed by Vision Rt Limited with the FDA for Gatect-rt.

Pre-market Notification Details

Device IDK072171
510k NumberK072171
Device Name:GATECT-RT
ClassificationAccelerator, Linear, Medical
Applicant VISION RT LIMITED 1244 FAIRWAY VALLEY COURT Lincoln,  CA  95648
ContactRobert J Morton, M.s.
CorrespondentRobert J Morton, M.s.
VISION RT LIMITED 1244 FAIRWAY VALLEY COURT Lincoln,  CA  95648
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-06
Decision Date2007-10-01
Summary:summary

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