System, Therapeutic, X-ray

Product Code: JAD

Radiology Therapeutic X-Ray Systems

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.5900


Radiation TypeIonizing
Radition SafetyAbbreviated
Annual ReportsYes

Products Classified as JAD

5355System, Therapeutic, X-rayX-ray Radiation Therapy System.

Total Product Life Cycle (TPLC) Devices

5355System, Therapeutic, X-rayX-ray Radiation Therapy System.

FDA Consensus Standards

System, Therapeutic, X-Ray [32082]21 CFR §892.5900 🔎
System, Therapeutic, X-Ray [28999]21 CFR §892.5900 🔎
System, Therapeutic, X-Ray [34832]21 CFR §892.5900 🔎
System, Therapeutic, X-Ray [29957]21 CFR §892.5900 🔎

Pre-market Notifications for JAD

K213942EsteyaNucletron B.V.
K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc
K182641Sensus IORT SystemSensus Healthcare, Inc.
K173425SRT-100+Sensus Healthcare, Inc.
K172080Photoelectric Therapy SystemXstrahl Ltd.
K162568INTRABEAM 600CARL ZEISS MEDITEC AG
K153570Axxent Electronic Brachytherapy System Model 110 XP 1200ICAD INC.
K150037Sensus Healthcare Superficial X-ray Radiation Therapy System With Ultrasonic Imaging CapabilitiesSENSUS HEALTHCARE
K141343AXXENT CERVICAL APPLICATORICAD, INC.
K132092ESTEYANUCLETRON B.V.
K131582SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEMSENSUS HEALTHCARE
K130549INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATORCARL ZEISS MEDITEC INC
K123985SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100SENSUS HEALTHCARE
K122951XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110ICAD, INC.
K121653INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORSCARL ZEISS MEDITEC, INC.

Global Unique Device Identification Database

00089904111227System, Therapeutic, X-Ray
00089904010827System, Therapeutic, X-Ray
00089904010742System, Therapeutic, X-Ray
00089904010735System, Therapeutic, X-Ray
00089904010384System, Therapeutic, X-Ray
00089904009876System, Therapeutic, X-Ray
00089904009371System, Therapeutic, X-Ray
00089904008398System, Therapeutic, X-Ray
00089904008084System, Therapeutic, X-Ray
00089904008077System, Therapeutic, X-Ray
00089904007971System, Therapeutic, X-Ray
00089904007964System, Therapeutic, X-Ray
00089904007810System, Therapeutic, X-Ray
00089904007537System, Therapeutic, X-Ray
00089904006516System, Therapeutic, X-Ray

Maude Adverse Events

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDARY OF ICAD, INC.2019-10-02
SENSUS HEALTHCARE SRT-100 VISIONSENSUS HEALTHCARE, INC2019-08-28
SENSUS HEALTHCARE SRT-100SENSUS HEALTHCARE, INC2019-08-23
INTRABEAM IORTCARL ZEISS MEDITEC AG (OBERKOCHEN)2019-07-22
INTRABEAM IORTCARL ZEISS MEDITEC, INC.2019-07-09
SENSUS HEALTHCARE SRT-100SENSUS HEALTHCARE, INC2019-07-05
SENSUS HEALTHCARE SRT-100SENSUS HEALTHCARE, INC2019-06-28
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDIARY OF ICAD, INC.2019-01-28
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDARY OF ICAD, INC.2018-08-27
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDIARY OF ICAD, INC.2018-06-29
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDIARY OF ICAD, INC.2018-06-29
AXXENT E BX BALLOON APPLICATOR KITXOFT, A SUBSIDIARY OF ICAD, INC.2017-12-06
SENSUS HEALTHCARE SRT-100SENSUS HEALTHCARE2017-02-15
SENSUS HEALTHCARE SRT-100SENSUS HEALTHCARE2017-02-10
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDARY OF ICAD2016-09-23
INTRABEAM NEEDLE APPLICATORCARL ZEISS MEDITEC AG (OBERKOCHEN)2016-08-02
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDIARY OF ICAD, INC.2016-05-20
SENSUS SRT-100SENSUS HEALTHCARE LLC2016-05-16
INTRABEAM SYSTEMCARL ZEISS MEDITEC AG (OBERKOCHEN)2016-04-15
AXXENTXOFT, A SUBSIDIARY OF ICAD2015-11-04
AXXENTXOFT, A SUBSIDIARY OF ICAD2015-11-02
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDIARY OF ICAD, INC.2015-10-28
AXXENTXOFT, A SUBSIDIARY OF ICAD2015-01-15
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDARY OF ICAD2014-09-16
XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDIARY OF ICAD, INC.2014-05-14
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDIARY OF ICAD, INC.2014-03-23
XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDIARY OF ICAD, INC.2014-03-07
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDIARY OF ICAD, INC.2013-12-09
ACCENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDIARY OF ICAN, INC.2013-08-26
ACCENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDIARY ICAD, INC.2013-08-19
INTRABEAM SYSTEMCARL ZEISS MEDITEC AG (SITE OBERKOCHEN)2013-07-11
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDIARY OF ICAD INC.2013-05-23
INTRABEAM SYSTEMCARL ZEISS MEDITEC AG2013-05-08
INTRABEAM SYSTEMCARL ZEISS MEDITEC AG2013-05-08
X DR SERIES 1600IMAGING DYNAMICS COMPANY LTD.2013-04-05
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, A SUBSIDIARY OF ICAD2013-04-01
INTRABEAM SYSTEMCARL ZEISS MEDITEC AG (SITE OBERKOCHEN)2013-02-26
INTRABEAMCARL ZEISS MEDITEC AG2013-02-12
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT2013-02-11
INTRABEAM BALLOON APPLICATORCARL ZEISS MEDITEC AG2012-10-29
INTRABEAM BALLOON APPLICATORCARL ZEISS MEDITEC AG2012-10-04
DERMOPAN-1 SYSTEMSIEMENS MED SOLUTIONS USA, INC.2012-03-09
BALLOON APPLICATOR KIT 3-4 SPHERICALXOFT, INC.2012-01-12
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, INC.2011-07-29
RADIATION SHIELDCARL ZEISS MEDITEC AG2011-07-01
BALLOON APPLICATOR KIT - 3-4 SPHERICALXOFT, INC.2011-04-29
BALLOON APPLICATOR KIT - 5-6 SPHERICALXOFT, INC.2009-10-23
BALLOON APPLICATOR KIT - 3-4 SPHERICALXOFT, INC.2009-10-08
BALLOON APPLICATOR KIT - 3-4 SPHERICALXOFT, INC.2009-06-26
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, INC.2009-04-08
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