IMPACT And X-Ranger

System, X-ray, Mobile

MinXray, Inc.

The following data is part of a premarket notification filed by Minxray, Inc. with the FDA for Impact And X-ranger.

Pre-market Notification Details

Device IDK210479
510k NumberK210479
Device Name:IMPACT And X-Ranger
ClassificationSystem, X-ray, Mobile
Applicant MinXray, Inc. 3611 Commercial Avenue Northbrook,  IL  60062
ContactKeith Kretchmer
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-19
Decision Date2021-03-19

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