Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM

System, X-ray, Stationary

CONTROL-X MEDICAL, INC.

The following data is part of a premarket notification filed by Control-x Medical, Inc. with the FDA for Z-motion Digital Diagnostic X-ray System.

Pre-market Notification Details

Device IDK102680
510k NumberK102680
Device Name:Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM
ClassificationSystem, X-ray, Stationary
Applicant CONTROL-X MEDICAL, INC. 1755 ATLAS ST. Columbus,  OH  43228
ContactLaszlo Adrovitz
CorrespondentLaszlo Adrovitz
CONTROL-X MEDICAL, INC. 1755 ATLAS ST. Columbus,  OH  43228
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-17
Decision Date2010-10-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05999116186126 K102680 000

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