Collision Check

Accelerator, Linear, Medical

Radformation, Inc.

The following data is part of a premarket notification filed by Radformation, Inc. with the FDA for Collision Check.

Pre-market Notification Details

Device IDK171350
510k NumberK171350
Device Name:Collision Check
ClassificationAccelerator, Linear, Medical
Applicant Radformation, Inc. 335 Madison Avenue 16th Floor New York,  NY  10017
ContactKurt Sysock
CorrespondentKurt Sysock
Radformation, Inc. 335 Madison Avenue 16th Floor New York,  NY  10017
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-09
Decision Date2017-11-29
Summary:summary

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