FDA 510(k) Applications for Medical Device Product Code "JAD"
(System, Therapeutic, X-Ray)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K162568 | CARL ZEISS MEDITEC AG | INTRABEAM 600 | 12/15/2016 |
| K130549 | CARL ZEISS MEDITEC INC | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR | 06/26/2013 |
| K121653 | CARL ZEISS MEDITEC, INC. | INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS | 12/27/2012 |
| K110590 | CARL ZEISS SURGICAL GMBH | INTRABEAM NEEDLE APPLICATOR | 04/13/2012 |
| K051055 | CARL ZEISS SURGICAL GMBH | INTRABEAM SYSTEM | 05/23/2005 |
| K090584 | CARL ZEISS SURGICAL GMBH | INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS | 11/24/2009 |
| K962613 | GULMAY MEDICAL LTD. | DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM | 09/27/1996 |
| K153570 | ICAD INC. | Axxent Electronic Brachytherapy System Model 110 XP 1200 | 02/25/2016 |
| K141343 | ICAD, INC. | AXXENT CERVICAL APPLICATOR | 09/05/2014 |
| K122951 | ICAD, INC. | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 | 01/17/2013 |
| K132092 | NUCLETRON B.V. | ESTEYA | 09/26/2013 |
| K213942 | Nucletron B.V. | Esteya | 01/11/2022 |
| K973315 | PANTAK, INC. | THERAPAX DXT 300 MODEL HF-300 | 12/02/1997 |
| K971074 | PANTAK, INC. | THERAPAX SXT 150 | 06/13/1997 |
| K980526 | PEC PHOTOELECTRON CORP. | PHOTON RADIOSURGERY SYSTEM PRS400 | 07/27/1998 |
| K964947 | PHOTOELECTRON CORPORATION | PHOTON RADIOSURGERY SYSTEM (PRS) | 06/20/1997 |
| K992577 | PHOTOELECTRON CORPORATION | PHOTON RADIOSURGERY SYSTEM (PRS) | 09/23/1999 |
| K123985 | SENSUS HEALTHCARE | SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 | 05/14/2013 |
| K150037 | SENSUS HEALTHCARE | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities | 10/16/2015 |
| K131582 | SENSUS HEALTHCARE | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM | 08/28/2013 |
| K190255 | Sensus Healthcare, Inc | Sensus Healthcare TVM Balloon Applicator | 02/21/2019 |
| K182641 | Sensus Healthcare, Inc. | Sensus IORT System | 02/21/2019 |
| K173425 | Sensus Healthcare, Inc. | SRT-100+ | 03/23/2018 |
| K063456 | TOPEX, INC | SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM | 01/09/2007 |
| K964952 | VICTOREEN, INC. | VERIDOSE V (FIVE), MODEL NUMBER 37-705 | 07/21/1997 |
| K111299 | XOFT, AN ICAD COMPANY | AXXENT RADIATION SHIELD - RIGID | 07/20/2011 |
| K090914 | XOFT, INC. | AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E | 07/16/2009 |
| K050843 | XOFT, INC. | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | 12/22/2005 |
| K072683 | XOFT, INC. | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | 02/29/2008 |
| K083734 | XOFT, INC. | AXXENT SURFACE APPLICATOR, MODEL 710257 | 02/11/2009 |
| K072616 | XOFT, INC. | AXXENT VAGINAL APPLICATOR | 05/09/2008 |
| K230611 | Xstrahl Ltd | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | 07/13/2023 |
| K172080 | Xstrahl Ltd. | Photoelectric Therapy System | 09/29/2017 |
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