Product code JAD
- Device name
- System, Therapeutic, X-Ray
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.5900
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250692 | GentleBeam (GB1000) | Voxel Ray Solutions, LLC | 2025-12-03 |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | Carl Zeiss Meditec, AG | 2025-01-10 |
| K230611 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | Xstrahl, Ltd. | 2023-07-13 |
| K213942 | Esteya | Nucletron B.V. | 2022-01-11 |
| K190255 | Sensus Healthcare TVM Balloon Applicator | Sensus Healthcare, Inc. | 2019-02-21 |
| K182641 | Sensus IORT System | Sensus Healthcare, Inc. | 2019-02-21 |
| K173425 | SRT-100+ | Sensus Healthcare, Inc. | 2018-03-23 |
| K172080 | Photoelectric Therapy System | Xstrahl, Ltd. | 2017-09-29 |
| K162568 | INTRABEAM 600 | Carl Zeiss Meditec, AG | 2016-12-15 |
| K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | Icad, Inc. | 2016-02-25 |
| K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities | Sensus Healthcare | 2015-10-16 |
| K141343 | AXXENT CERVICAL APPLICATOR | Icad, Inc. | 2014-09-05 |
| K132092 | ESTEYA | Nucletron B.V. | 2013-09-26 |
| K131582 | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM | Sensus Healthcare | 2013-08-28 |
| K130549 | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR | Carl Zeiss Meditec, Inc. | 2013-06-26 |
| K123985 | SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 | Sensus Healthcare | 2013-05-14 |
| K122951 | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 | Icad, Inc. | 2013-01-17 |
| K121653 | INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS | Carl Zeiss Meditec, Inc. | 2012-12-27 |
| K110590 | INTRABEAM NEEDLE APPLICATOR | Carl Zeiss Surgical GmbH | 2012-04-13 |
| K111299 | AXXENT RADIATION SHIELD - RIGID | Xoft, an Icad Company | 2011-07-20 |
| K090584 | INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS | Carl Zeiss Surgical GmbH | 2009-11-24 |
| K090914 | AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E | Xoft, Inc. | 2009-07-16 |
| K083734 | AXXENT SURFACE APPLICATOR, MODEL 710257 | Xoft, Inc. | 2009-02-11 |
| K072616 | AXXENT VAGINAL APPLICATOR | Xoft, Inc. | 2008-05-09 |
| K072683 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | Xoft, Inc. | 2008-02-29 |
| K063456 | SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM | Topex, Inc. | 2007-01-09 |
| K050843 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | Xoft, Inc. | 2005-12-22 |
| K051055 | INTRABEAM SYSTEM | Carl Zeiss Surgical GmbH | 2005-05-23 |
| K992577 | PHOTON RADIOSURGERY SYSTEM (PRS) | Photoelectron Corporation | 1999-09-23 |
| K980526 | PHOTON RADIOSURGERY SYSTEM PRS400 | Pec Photoelectron Corp. | 1998-07-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04049539105509 | INTRABEAM Spherical Sizer Set | Carl Zeiss Meditec AG | 2025-06-20 |
| 04049539105516 | INTRABEAM SMART Spherical Applicator | Carl Zeiss Meditec AG | 2025-05-14 |
| 04049539105523 | INTRABEAM SMART Spherical Applicator | Carl Zeiss Meditec AG | 2025-05-14 |
| 04049539105530 | INTRABEAM SMART Spherical Applicator | Carl Zeiss Meditec AG | 2025-05-14 |
| 04049539105547 | INTRABEAM SMART Spherical Applicator (35 mm) | Carl Zeiss Meditec AG | 2025-05-14 |
| 04049539105578 | INTRABEAM SMART Spherical Applicator (45mm) | Carl Zeiss Meditec AG | 2025-05-14 |
| 04049539105561 | INTRABEAM SMART Spherical Applicator (40mm) | Carl Zeiss Meditec AG | 2025-05-14 |
| 04049539105554 | INTRABEAM SMART Spherical Applicator (35mm) | Carl Zeiss Meditec AG | 2025-05-14 |
| 04049539066503 | INTRABEAM SMART Stand | Carl Zeiss Meditec AG | 2025-04-01 |
| 04049539064080 | INTRABEAM | Carl Zeiss Meditec AG | 2025-04-01 |
| 10850002237037 | Sensus | SENSUS HEALTHCARE, INC. | 2018-12-12 |
| 10850002237020 | Sensus | SENSUS HEALTHCARE, INC. | 2018-12-12 |
| 10850002237013 | Sensus | SENSUS HEALTHCARE, INC. | 2018-12-12 |
| 08717213038844 | Esteya | Nucletron B.V. | 2018-06-12 |
| 08717213038837 | Esteya | Nucletron B.V. | 2018-06-12 |
| 08717213038820 | Esteya | Nucletron B.V. | 2018-06-12 |
| 08717213051041 | Esteya | Nucletron B.V. | 2016-10-11 |
| 08717213051058 | Esteya | Nucletron B.V. | 2016-10-11 |
| 08717213051034 | Esteya | Nucletron B.V. | 2016-10-11 |
| 08717213051027 | Esteya | Nucletron B.V. | 2016-10-11 |
| 08717213051010 | Esteya | Nucletron B.V. | 2016-10-11 |
| 08717213050990 | Esteya | Nucletron B.V. | 2016-10-10 |
| 08717213050983 | Esteya | Nucletron B.V. | 2016-10-10 |
| 08717213050976 | Esteya | Nucletron B.V. | 2016-10-08 |
| 08717213036086 | Esteya | Nucletron B.V. | 2016-09-28 |
| 08717213051003 | Esteya | Nucletron B.V. | 2016-09-28 |
| 08717213039179 | Esteya | Nucletron B.V. | 2016-09-10 |
| 08717213039162 | Esteya | Nucletron B.V. | 2016-09-10 |
| 08717213036161 | Esteya | Nucletron B.V. | 2016-09-10 |
| 08717213036109 | Esteya | Nucletron B.V. | 2016-09-10 |