System, Therapeutic, X-Ray
Regulation 892.5900
1510(k)s in 12 months (53 all time)
1recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in JAD
| Company | 510(k)s | Recalls |
|---|---|---|
| Carl Zeiss Meditec, AG | 4 | 6 |
| Sensus Healthcare | 6 | 1 |
| Xoft, Inc. | 5 | 0 |
| Xstrahl, Ltd. | 2 | 3 |
| Action Products, Inc. | 1 | 2 |
| Carl Zeiss Surgical GmbH | 3 | 0 |
| Icad, Inc. | 3 | 0 |
| Adac Laboratories | 2 | 0 |
| Emi Therapy Systems, Inc. | 2 | 0 |
| Nucletron B.V. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 3, 2025 | K250692 | GentleBeam (GB1000) Voxel Ray Solutions, LLC | JAD |
| Jan 10, 2025 | K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Carl Zeiss Meditec, AG, DE | JAD |
| Jul 13, 2023 | K230611 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) Xstrahl, Ltd., GB | JAD |
| Jan 11, 2022 | K213942 | Esteya Nucletron B.V., NL | JAD |
| Feb 21, 2019 | K190255 | Sensus Healthcare TVM Balloon Applicator Sensus Healthcare, Inc. | JAD |
| Feb 21, 2019 | K182641 | Sensus IORT System Sensus Healthcare, Inc. | JAD |
| Mar 23, 2018 | K173425 | SRT-100+ Sensus Healthcare, Inc. | JAD |
| Sep 29, 2017 | K172080 | Photoelectric Therapy System Xstrahl, Ltd., GB | JAD |
| Dec 15, 2016 | K162568 | INTRABEAM 600 Carl Zeiss Meditec, AG, DE | JAD |
| Feb 25, 2016 | K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 Icad, Inc. | JAD |
| Oct 16, 2015 | K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities Sensus Healthcare | JAD |
| Sep 5, 2014 | K141343 | AXXENT CERVICAL APPLICATOR Icad, Inc. | JAD |
| Sep 26, 2013 | K132092 | ESTEYA Nucletron B.V. | JAD |
| Aug 28, 2013 | K131582 | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM Sensus Healthcare | JAD |
| Jun 26, 2013 | K130549 | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR Carl Zeiss Meditec, Inc. | JAD |
| May 14, 2013 | K123985 | SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 Sensus Healthcare | JAD |
| Jan 17, 2013 | K122951 | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 Icad, Inc. | JAD |
| Dec 27, 2012 | K121653 | INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS Carl Zeiss Meditec, Inc. | JAD |
| Apr 13, 2012 | K110590 | INTRABEAM NEEDLE APPLICATOR Carl Zeiss Surgical GmbH | JAD |
| Jul 20, 2011 | K111299 | AXXENT RADIATION SHIELD - RIGID Xoft, an Icad Company | JAD |
| Nov 24, 2009 | K090584 | INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS Carl Zeiss Surgical GmbH | JAD |
| Jul 16, 2009 | K090914 | AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E Xoft, Inc. | JAD |
| Feb 11, 2009 | K083734 | AXXENT SURFACE APPLICATOR, MODEL 710257 Xoft, Inc. | JAD |
| May 9, 2008 | K072616 | AXXENT VAGINAL APPLICATOR Xoft, Inc. | JAD |
| Feb 29, 2008 | K072683 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM Xoft, Inc. | JAD |
| Jan 9, 2007 | K063456 | SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM Topex, Inc. | JAD |
| Dec 22, 2005 | K050843 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM Xoft, Inc. | JAD |
| May 23, 2005 | K051055 | INTRABEAM SYSTEM Carl Zeiss Surgical GmbH | JAD |
| Sep 23, 1999 | K992577 | PHOTON RADIOSURGERY SYSTEM (PRS) Photoelectron Corporation | JAD |
| Jul 27, 1998 | K980526 | PHOTON RADIOSURGERY SYSTEM PRS400 Pec Photoelectron Corp. | JAD |
| Dec 2, 1997 | K973315 | THERAPAX DXT 300 MODEL HF-300 Pantak, Inc. | JAD |
| Jul 21, 1997 | K964952 | VERIDOSE V (FIVE), MODEL NUMBER 37-705 Victoreen, Inc. | JAD |
| Jun 20, 1997 | K964947 | PHOTON RADIOSURGERY SYSTEM (PRS) Photoelectron Corporation | JAD |
| Jun 13, 1997 | K971074 | THERAPAX SXT 150 Pantak, Inc. | JAD |
| Sep 27, 1996 | K962613 | DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM Gulmay Medical , Ltd., GB | JAD |
| Dec 13, 1993 | K935209 | INSTA-FLO Medtec, Inc. | JAD |
| Jan 15, 1993 | K923584 | THERAPAX DXT 300 SERIES 3 Oldelft Corp. of America | JAD |
| Nov 29, 1990 | K904005 | HUESTIS FLEXI-BOARD Huestis Machine Corp. | JAD |
| Sep 21, 1990 | K903377 | COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION Siemens Medical Solutions USA, Inc. | JAD |
| Sep 7, 1989 | K894683 | FABFOAM #302 Jewell Industries | JAD |
| Dec 21, 1988 | K882484 | CMS RECORD AND VERIFY SYSTEM Computerized Medical Systems, Inc. | JAD |
| Feb 22, 1988 | K874214 | S9 DISPLAY SYSTEM O.M.I. Oncology Microsystems, Inc., CA | JAD |
| Oct 30, 1987 | K871810 | PLAN-32 SOFTWARE Oncology Systems, Inc. | JAD |
| May 21, 1986 | K861431 | THERAPAX HT 150T Old Delft Corp. of America | JAD |
| Feb 21, 1986 | K854609 | MEVAMATIC 3 Siemens Medical Laboratories, Inc. | JAD |
| Feb 21, 1985 | K844424 | INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10 Varian Assoc., Inc. | JAD |
| Dec 8, 1983 | K833560 | RTP-5100-5200-5300 & 5400 Adac Laboratories | JAD |
| Jan 22, 1982 | K813439 | RTP-5000 Adac Laboratories | JAD |
| Jul 10, 1981 | K811528 | RADIATION BOLUS Action Products, Inc. | JAD |
| Jul 18, 1978 | K781084 | THERAPAX 150A Emi Therapy Systems, Inc. | JAD |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.