O-ARM IMAGING SYSTEM

Image-intensified Fluoroscopic X-ray System, Mobile

BREAKAWAY IMAGING, LLC

The following data is part of a premarket notification filed by Breakaway Imaging, Llc with the FDA for O-arm Imaging System.

Pre-market Notification Details

Device IDK060344
510k NumberK060344
Device Name:O-ARM IMAGING SYSTEM
ClassificationImage-intensified Fluoroscopic X-ray System, Mobile
Applicant BREAKAWAY IMAGING, LLC 300 FOSTER STREET Littleton,  MA  01460
ContactRick Grant
CorrespondentRick Grant
BREAKAWAY IMAGING, LLC 300 FOSTER STREET Littleton,  MA  01460
Product CodeOXO  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-10
Decision Date2006-03-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20885074546180 K060344 000
20643169803002 K060344 000
20643169868131 K060344 000

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