Product Code: JAD FDA class 2 21 CFR 892.5900

System, Therapeutic, X-Ray

Radiology

A therapeutic X-ray system is used in radiation therapy to deliver controlled doses of X-ray radiation for the treatment of malignant and benign tumors and other conditions, encompassing the full range of voltage configurations used in external beam radiotherapy. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before commercial distribution. The product code is JAD, regulated under 21 CFR 892.5900, within the Radiology medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: JAD
Device Class: FDA class 2
Regulation Number: 892.5900
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 53 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250692	GentleBeam (GB1000)	Dec 03, 2025	Substantially Equivalent	Voxel Ray Solutions, LLC
K241174	INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)	Jan 10, 2025	Substantially Equivalent	Carl Zeiss Meditec, AG
K230611	X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)	Jul 13, 2023	Substantially Equivalent	Xstrahl, Ltd.
K213942	Esteya	Jan 11, 2022	Substantially Equivalent	Nucletron B.V.
K190255	Sensus Healthcare TVM Balloon Applicator	Feb 21, 2019	Substantially Equivalent	Sensus Healthcare, Inc.
K182641	Sensus IORT System	Feb 21, 2019	Substantially Equivalent	Sensus Healthcare, Inc.
K173425	SRT-100+	Mar 23, 2018	Substantially Equivalent	Sensus Healthcare, Inc.
K172080	Photoelectric Therapy System	Sep 29, 2017	Substantially Equivalent	Xstrahl, Ltd.
K162568	INTRABEAM 600	Dec 15, 2016	Substantially Equivalent	Carl Zeiss Meditec, AG
K153570	Axxent Electronic Brachytherapy System Model 110 XP 1200	Feb 25, 2016	Substantially Equivalent	Icad, Inc.
K150037	Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities	Oct 16, 2015	Substantially Equivalent	Sensus Healthcare
K141343	AXXENT CERVICAL APPLICATOR	Sep 05, 2014	Substantially Equivalent	Icad, Inc.
K132092	ESTEYA	Sep 26, 2013	Substantially Equivalent	Nucletron B.V.
K131582	SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM	Aug 28, 2013	Substantially Equivalent	Sensus Healthcare
K130549	INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR	Jun 26, 2013	Substantially Equivalent	Carl Zeiss Meditec, Inc.
K123985	SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100	May 14, 2013	Substantially Equivalent	Sensus Healthcare
K122951	XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110	Jan 17, 2013	Substantially Equivalent	Icad, Inc.
K121653	INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS	Dec 27, 2012	Substantially Equivalent	Carl Zeiss Meditec, Inc.
K110590	INTRABEAM NEEDLE APPLICATOR	Apr 13, 2012	Substantially Equivalent	Carl Zeiss Surgical GmbH
K111299	AXXENT RADIATION SHIELD - RIGID	Jul 20, 2011	Substantially Equivalent	Xoft, an Icad Company
K090584	INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS	Nov 24, 2009	Substantially Equivalent	Carl Zeiss Surgical GmbH
K090914	AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E	Jul 16, 2009	Unknown	Xoft, Inc.
K083734	AXXENT SURFACE APPLICATOR, MODEL 710257	Feb 11, 2009	Substantially Equivalent	Xoft, Inc.
K072616	AXXENT VAGINAL APPLICATOR	May 09, 2008	Substantially Equivalent	Xoft, Inc.
K072683	AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM	Feb 29, 2008	Unknown	Xoft, Inc.
K063456	SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM	Jan 09, 2007	Substantially Equivalent	Topex, Inc.
K050843	AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM	Dec 22, 2005	Unknown	Xoft, Inc.
K051055	INTRABEAM SYSTEM	May 23, 2005	Substantially Equivalent	Carl Zeiss Surgical GmbH
K992577	PHOTON RADIOSURGERY SYSTEM (PRS)	Sep 23, 1999	Substantially Equivalent	Photoelectron Corporation
K980526	PHOTON RADIOSURGERY SYSTEM PRS400	Jul 27, 1998	Substantially Equivalent	Pec Photoelectron Corp.
K973315	THERAPAX DXT 300 MODEL HF-300	Dec 02, 1997	Substantially Equivalent	Pantak, Inc.
K964952	VERIDOSE V (FIVE), MODEL NUMBER 37-705	Jul 21, 1997	Substantially Equivalent	Victoreen, Inc.
K964947	PHOTON RADIOSURGERY SYSTEM (PRS)	Jun 20, 1997	Substantially Equivalent	Photoelectron Corporation
K971074	THERAPAX SXT 150	Jun 13, 1997	Substantially Equivalent	Pantak, Inc.
K962613	DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM	Sep 27, 1996	Substantially Equivalent	Gulmay Medical , Ltd.
K935209	INSTA-FLO	Dec 13, 1993	Substantially Equivalent	Medtec, Inc.
K923584	THERAPAX DXT 300 SERIES 3	Jan 15, 1993	Substantially Equivalent	Oldelft Corp. of America
K904005	HUESTIS FLEXI-BOARD	Nov 29, 1990	Substantially Equivalent	Huestis Machine Corp.
K903377	COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION	Sep 21, 1990	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K894683	FABFOAM #302	Sep 07, 1989	Substantially Equivalent	Jewell Industries
K882484	CMS RECORD AND VERIFY SYSTEM	Dec 21, 1988	Substantially Equivalent	Computerized Medical Systems, Inc.
K874214	S9 DISPLAY SYSTEM	Feb 22, 1988	Substantially Equivalent	O.M.I. Oncology Microsystems, Inc.
K871810	PLAN-32 SOFTWARE	Oct 30, 1987	Substantially Equivalent	Oncology Systems, Inc.
K861431	THERAPAX HT 150T	May 21, 1986	Substantially Equivalent	Old Delft Corp. of America
K854609	MEVAMATIC 3	Feb 21, 1986	Substantially Equivalent	Siemens Medical Laboratories, Inc.
K844424	INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10	Feb 21, 1985	Substantially Equivalent	Varian Assoc., Inc.
K833560	RTP-5100-5200-5300 & 5400	Dec 08, 1983	Substantially Equivalent	Adac Laboratories
K813439	RTP-5000	Jan 22, 1982	Substantially Equivalent	Adac Laboratories
K811528	RADIATION BOLUS	Jul 10, 1981	Substantially Equivalent	Action Products, Inc.
K781084	THERAPAX 150A	Jul 18, 1978	Substantially Equivalent	Emi Therapy Systems, Inc.
K780278	RADIATION THERAPY TREAT. PLAN. SYS.	Mar 02, 1978	Substantially Equivalent	Pfizer Medical Systems, Inc.
K780157	RADIATION TREATMENT PLANNING SYSTEM	Feb 13, 1978	Substantially Equivalent	Capintec, Inc.
K771817	EMI THERAPY SIMULATOR	Jan 13, 1978	Substantially Equivalent	Emi Therapy Systems, Inc.