FDA Product Code
FDA Product Code JAD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5900
510(k) Clearances — 53 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250692 | GentleBeam (GB1000) | Voxel Ray Solutions, LLC | 2025-12-03 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K230611 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | Xstrahl, Ltd. | 2023-07-13 | Traditional | PDF ↗ |
| K213942 | Esteya | Nucletron B.V. | 2022-01-11 | Traditional | PDF ↗ |
| K182641 | Sensus IORT System | Sensus Healthcare, Inc. | 2019-02-21 | Traditional | PDF ↗ |
| K190255 | Sensus Healthcare TVM Balloon Applicator | Sensus Healthcare, Inc. | 2019-02-21 | Traditional | PDF ↗ |
| K173425 | SRT-100+ | Sensus Healthcare, Inc. | 2018-03-23 | Traditional | PDF ↗ |
| K172080 | Photoelectric Therapy System | Xstrahl, Ltd. | 2017-09-29 | Traditional | PDF ↗ |
| K162568 | INTRABEAM 600 | Carl Zeiss Meditec, AG | 2016-12-15 | Traditional | PDF ↗ |
| K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | Icad, Inc. | 2016-02-25 | Traditional | PDF ↗ |
| K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities | Sensus Healthcare | 2015-10-16 | Traditional | PDF ↗ |
| K141343 | AXXENT CERVICAL APPLICATOR | Icad, Inc. | 2014-09-05 | Traditional | PDF ↗ |
| K132092 | ESTEYA | Nucletron B.V. | 2013-09-26 | Traditional | PDF ↗ |
| K131582 | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM | Sensus Healthcare | 2013-08-28 | Traditional | PDF ↗ |
| K130549 | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR | Carl Zeiss Meditec, Inc. | 2013-06-26 | Traditional | PDF ↗ |
| K123985 | SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 | Sensus Healthcare | 2013-05-14 | Traditional | PDF ↗ |
| K122951 | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 | Icad, Inc. | 2013-01-17 | Traditional | PDF ↗ |
| K121653 | INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS | Carl Zeiss Meditec, Inc. | 2012-12-27 | Traditional | PDF ↗ |
| K110590 | INTRABEAM NEEDLE APPLICATOR | Carl Zeiss Surgical GmbH | 2012-04-13 | Traditional | PDF ↗ |
| K111299 | AXXENT RADIATION SHIELD - RIGID | Xoft, an Icad Company | 2011-07-20 | Traditional | PDF ↗ |
| K090584 | INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS | Carl Zeiss Surgical GmbH | 2009-11-24 | Traditional | PDF ↗ |
| K090914 | AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E | Xoft, Inc. | 2009-07-16 | Traditional | PDF ↗ |
| K083734 | AXXENT SURFACE APPLICATOR, MODEL 710257 | Xoft, Inc. | 2009-02-11 | Traditional | PDF ↗ |
| K072616 | AXXENT VAGINAL APPLICATOR | Xoft, Inc. | 2008-05-09 | Traditional | PDF ↗ |
| K072683 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | Xoft, Inc. | 2008-02-29 | Traditional | PDF ↗ |
| K063456 | SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM | Topex, Inc. | 2007-01-09 | Traditional | PDF ↗ |
| K050843 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | Xoft, Inc. | 2005-12-22 | Traditional | PDF ↗ |
| K051055 | INTRABEAM SYSTEM | Carl Zeiss Surgical GmbH | 2005-05-23 | Special | PDF ↗ |
| K992577 | PHOTON RADIOSURGERY SYSTEM (PRS) | Photoelectron Corporation | 1999-09-23 | Traditional | PDF ↗ |
| K980526 | PHOTON RADIOSURGERY SYSTEM PRS400 | Pec Photoelectron Corp. | 1998-07-27 | Traditional | PDF ↗ |
| K973315 | THERAPAX DXT 300 MODEL HF-300 | Pantak, Inc. | 1997-12-02 | Traditional | PDF ↗ |
| K964952 | VERIDOSE V (FIVE), MODEL NUMBER 37-705 | Victoreen, Inc. | 1997-07-21 | Traditional | PDF ↗ |
| K964947 | PHOTON RADIOSURGERY SYSTEM (PRS) | Photoelectron Corporation | 1997-06-20 | Traditional | PDF ↗ |
| K971074 | THERAPAX SXT 150 | Pantak, Inc. | 1997-06-13 | Traditional | PDF ↗ |
| K962613 | DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM | Gulmay Medical , Ltd. | 1996-09-27 | Traditional | PDF ↗ |
| K935209 | INSTA-FLO | Medtec, Inc. | 1993-12-13 | Traditional | PDF ↗ |
| K923584 | THERAPAX DXT 300 SERIES 3 | Oldelft Corp. of America | 1993-01-15 | Traditional | PDF ↗ |
| K904005 | HUESTIS FLEXI-BOARD | Huestis Machine Corp. | 1990-11-29 | Traditional | PDF ↗ |
| K903377 | COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION | Siemens Medical Solutions USA, Inc. | 1990-09-21 | Traditional | PDF ↗ |
| K894683 | FABFOAM #302 | Jewell Industries | 1989-09-07 | Traditional | PDF ↗ |
| K882484 | CMS RECORD AND VERIFY SYSTEM | Computerized Medical Systems, Inc. | 1988-12-21 | Traditional | PDF ↗ |
| K874214 | S9 DISPLAY SYSTEM | O.M.I. Oncology Microsystems, Inc. | 1988-02-22 | Traditional | PDF ↗ |
| K871810 | PLAN-32 SOFTWARE | Oncology Systems, Inc. | 1987-10-30 | Traditional | PDF ↗ |
| K861431 | THERAPAX HT 150T | Old Delft Corp. of America | 1986-05-21 | Traditional | PDF ↗ |
| K854609 | MEVAMATIC 3 | Siemens Medical Laboratories, Inc. | 1986-02-21 | Traditional | PDF ↗ |
| K844424 | INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10 | Varian Assoc., Inc. | 1985-02-21 | Traditional | PDF ↗ |
| K833560 | RTP-5100-5200-5300 & 5400 | Adac Laboratories | 1983-12-08 | Traditional | PDF ↗ |
| K813439 | RTP-5000 | Adac Laboratories | 1982-01-22 | Traditional | PDF ↗ |
| K811528 | RADIATION BOLUS | Action Products, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K781084 | THERAPAX 150A | Emi Therapy Systems, Inc. | 1978-07-18 | Traditional | PDF ↗ |
| K780278 | RADIATION THERAPY TREAT. PLAN. SYS. | Pfizer Medical Systems, Inc. | 1978-03-02 | Traditional | PDF ↗ |
| K780157 | RADIATION TREATMENT PLANNING SYSTEM | Capintec, Inc. | 1978-02-13 | Traditional | PDF ↗ |
| K771817 | EMI THERAPY SIMULATOR | Emi Therapy Systems, Inc. | 1978-01-13 | Traditional | PDF ↗ |
Product code JAD · Class II · Radiology. Data: openFDA.