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System, Therapeutic, X-Ray

FDA product code JAD · 51 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.5900
Review panel: RA
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-01-13 – 2025-12-03

JAD 2025-12-03

GentleBeam (GB1000)

Applicant Voxel Ray Solutions, LLC

K number K250692

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JAD 2025-01-10

INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)

Applicant Carl Zeiss Meditec, AG

K number K241174

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JAD 2023-07-13

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)

Applicant Xstrahl, Ltd.

K number K230611

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JAD 2022-01-11

Esteya

Applicant Nucletron B.V.

K number K213942

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JAD 2019-02-21

Sensus Healthcare TVM Balloon Applicator

Applicant Sensus Healthcare, Inc.

K number K190255

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JAD 2019-02-21

Sensus IORT System

Applicant Sensus Healthcare, Inc.

K number K182641

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JAD 2018-03-23

SRT-100+

Applicant Sensus Healthcare, Inc.

K number K173425

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JAD 2017-09-29

Photoelectric Therapy System

Applicant Xstrahl, Ltd.

K number K172080

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JAD 2016-12-15

INTRABEAM 600

Applicant Carl Zeiss Meditec, AG

K number K162568

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JAD 2016-02-25

Axxent Electronic Brachytherapy System Model 110 XP 1200

Applicant Icad, Inc.

K number K153570

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JAD 2013-09-26

ESTEYA

Applicant Nucletron B.V.

K number K132092

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JAD 2013-08-28

SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM

Applicant Sensus Healthcare

K number K131582

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JAD 2013-06-26

INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR

Applicant Carl Zeiss Meditec, Inc.

K number K130549

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JAD 2013-05-14

SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100

Applicant Sensus Healthcare

K number K123985

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JAD 2013-01-17

XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110

Applicant Icad, Inc.

K number K122951

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JAD 2012-12-27

INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS

Applicant Carl Zeiss Meditec, Inc.

K number K121653

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JAD 2012-04-13

INTRABEAM NEEDLE APPLICATOR

Applicant Carl Zeiss Surgical GmbH

K number K110590

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JAD 2011-07-20

AXXENT RADIATION SHIELD - RIGID

Applicant Xoft, an Icad Company

K number K111299

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JAD 2009-11-24

INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS

Applicant Carl Zeiss Surgical GmbH

K number K090584

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JAD 2009-07-16

AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E

Applicant Xoft, Inc.

K number K090914

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JAD 2009-02-11

AXXENT SURFACE APPLICATOR, MODEL 710257

Applicant Xoft, Inc.

K number K083734

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JAD 2008-05-09

AXXENT VAGINAL APPLICATOR

Applicant Xoft, Inc.

K number K072616

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JAD 2008-02-29

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

Applicant Xoft, Inc.

K number K072683

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JAD 2007-01-09

SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM

Applicant Topex, Inc.

K number K063456

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JAD 2005-12-22

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

Applicant Xoft, Inc.

K number K050843

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JAD 2005-05-23

INTRABEAM SYSTEM

Applicant Carl Zeiss Surgical GmbH

K number K051055

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JAD 1999-09-23

PHOTON RADIOSURGERY SYSTEM (PRS)

Applicant Photoelectron Corporation

K number K992577

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JAD 1998-07-27

PHOTON RADIOSURGERY SYSTEM PRS400

Applicant Pec Photoelectron Corp.

K number K980526

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JAD 1997-12-02

THERAPAX DXT 300 MODEL HF-300

Applicant Pantak, Inc.

K number K973315

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JAD 1997-07-21

VERIDOSE V (FIVE), MODEL NUMBER 37-705

Applicant Victoreen, Inc.

K number K964952

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JAD 1997-06-20

PHOTON RADIOSURGERY SYSTEM (PRS)

Applicant Photoelectron Corporation

K number K964947

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JAD 1997-06-13

THERAPAX SXT 150

Applicant Pantak, Inc.

K number K971074

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JAD 1996-09-27

DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM

Applicant Gulmay Medical , Ltd.

K number K962613

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JAD 1993-12-13

INSTA-FLO

Applicant Medtec, Inc.

K number K935209

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JAD 1993-01-15

THERAPAX DXT 300 SERIES 3

Applicant Oldelft Corp. of America

K number K923584

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JAD 1990-11-29

HUESTIS FLEXI-BOARD

Applicant Huestis Machine Corp.

K number K904005

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JAD 1990-09-21

COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION

Applicant Siemens Medical Solutions USA, Inc.

K number K903377

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JAD 1989-09-07

FABFOAM #302

Applicant Jewell Industries

K number K894683

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JAD 1988-12-21

CMS RECORD AND VERIFY SYSTEM

Applicant Computerized Medical Systems, Inc.

K number K882484

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JAD 1988-02-22

S9 DISPLAY SYSTEM

Applicant O.M.I. Oncology Microsystems, Inc.

K number K874214

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JAD 1987-10-30

PLAN-32 SOFTWARE

Applicant Oncology Systems, Inc.

K number K871810

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JAD 1986-05-21

THERAPAX HT 150T

Applicant Old Delft Corp. of America

K number K861431

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JAD 1986-02-21

MEVAMATIC 3

Applicant Siemens Medical Laboratories, Inc.

K number K854609

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JAD 1985-02-21

INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10

Applicant Varian Assoc., Inc.

K number K844424

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JAD 1983-12-08

RTP-5100-5200-5300 & 5400

Applicant Adac Laboratories

K number K833560

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JAD 1982-01-22

RTP-5000

Applicant Adac Laboratories

K number K813439

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JAD 1981-07-10

RADIATION BOLUS

Applicant Action Products, Inc.

K number K811528

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JAD 1978-07-18

THERAPAX 150A

Applicant Emi Therapy Systems, Inc.

K number K781084

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JAD 1978-03-02

RADIATION THERAPY TREAT. PLAN. SYS.

Applicant Pfizer Medical Systems, Inc.

K number K780278

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JAD 1978-02-13

RADIATION TREATMENT PLANNING SYSTEM

Applicant Capintec, Inc.

K number K780157

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JAD 1978-01-13

EMI THERAPY SIMULATOR

Applicant Emi Therapy Systems, Inc.

K number K771817

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