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JAD — System, Therapeutic, X-Ray Class II

FDA Device Classification

Classification Details

Product Code
JAD
Device Class
Class II
Regulation Number
892.5900
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250692voxel ray solutionsGentleBeam (GB1000)December 3, 2025
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K190255sensus healthcareSensus Healthcare TVM Balloon ApplicatorFebruary 21, 2019
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K173425sensus healthcareSRT-100+March 23, 2018
K172080xstrahlPhotoelectric Therapy SystemSeptember 29, 2017
K162568carl zeiss meditecINTRABEAM 600December 15, 2016
K153570icadAxxent Electronic Brachytherapy System Model 110 XP 1200February 25, 2016
K150037sensus healthcareSensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic ImaOctober 16, 2015
K141343icadAXXENT CERVICAL APPLICATORSeptember 5, 2014
K132092nucletronESTEYASeptember 26, 2013
K131582sensus healthcareSENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEMAugust 28, 2013
K130549carl zeiss meditecINTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATORJune 26, 2013
K123985sensus healthcareSENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100May 14, 2013
K122951icadXOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110January 17, 2013
K121653carl zeiss meditecINTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORSDecember 27, 2012
K110590carl zeiss surgicalINTRABEAM NEEDLE APPLICATORApril 13, 2012
K111299xoft, an icadAXXENT RADIATION SHIELD - RIGIDJuly 20, 2011