FDA.reportPublic FDA data

510(k) K241174

Device
INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)
Applicant
Carl Zeiss Meditec, AG
510(k) number
K241174
Product code
JAD
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-10
Date received
2024-04-26
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
No

Applicant Contact#

Contact
Anke Seitz
Address
Rudolf-Eber-Strasse 11 Oberkochen DE 73447 73447

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
K250692GentleBeam (GB1000)Voxel Ray Solutions, LLC2025-12-03
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