FDA.reportPublic FDA data

510(k) K250692

Device
GentleBeam (GB1000)
Applicant
Voxel Ray Solutions, LLC
510(k) number
K250692
Product code
JAD
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-03
Date received
2025-03-07
Regulation
892.5900
Classification name
System, Therapeutic, X-Ray
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Nicolas Soro
Address
200 Frontage Rd. Suite 200 Burr Ridge IL US 60527 60527

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JAD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AG2025-01-10
K230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.2023-07-13
K213942EsteyaNucletron B.V.2022-01-11
K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.2019-02-21
K182641Sensus IORT SystemSensus Healthcare, Inc.2019-02-21
K173425SRT-100+Sensus Healthcare, Inc.2018-03-23
K172080Photoelectric Therapy SystemXstrahl, Ltd.2017-09-29
K162568INTRABEAM 600Carl Zeiss Meditec, AG2016-12-15
K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc.2016-02-25
K150037Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging CapabilitiesSensus Healthcare2015-10-16
K141343AXXENT CERVICAL APPLICATORIcad, Inc.2014-09-05
K132092ESTEYANucletron B.V.2013-09-26
K131582SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEMSensus Healthcare2013-08-28
K130549INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATORCarl Zeiss Meditec, Inc.2013-06-26
K123985SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100Sensus Healthcare2013-05-14