Axxent Electronic Brachytherapy System Model 110 XP 1200

System, Therapeutic, X-ray

ICAD INC.

The following data is part of a premarket notification filed by Icad Inc. with the FDA for Axxent Electronic Brachytherapy System Model 110 Xp 1200.

Pre-market Notification Details

Device IDK153570
510k NumberK153570
Device Name:Axxent Electronic Brachytherapy System Model 110 XP 1200
ClassificationSystem, Therapeutic, X-ray
Applicant ICAD INC. 98 SPITBROOK ROAD, SUITE 100 Nashua,  NH  03062
ContactJohn Delucia
CorrespondentJohn Delucia
ICAD INC. 98 SPITBROOK ROAD, SUITE 100 Nashua,  NH  03062
Product CodeJAD  
CFR Regulation Number892.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-14
Decision Date2016-02-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858012005526 K153570 000

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