Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JAD — Predicate Candidate Screening
53 FDA 510(k) clearances under this product code; the 50 most recent screened below.
95 daysmedian FDA review time
259 days90th percentile
53clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250692 | GentleBeam (GB1000) | Voxel Ray Solutions, LLC | 2025-12-03 | 271 | 0 |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INT | Carl Zeiss Meditec, AG | 2025-01-10 | 259 | 0 |
| K230611 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | Xstrahl, Ltd. | 2023-07-13 | 129 | 0 |
| K213942 | Esteya | Nucletron B.V. | 2022-01-11 | 25 | 0 |
| K190255 | Sensus Healthcare TVM Balloon Applicator | Sensus Healthcare, Inc. | 2019-02-21 | 14 | 0 |
| K182641 | Sensus IORT System | Sensus Healthcare, Inc. | 2019-02-21 | 150 | 0 |
| K173425 | SRT-100+ | Sensus Healthcare, Inc. | 2018-03-23 | 141 | 0 |
| K172080 | Photoelectric Therapy System | Xstrahl, Ltd. | 2017-09-29 | 81 | 0 |
| K162568 | INTRABEAM 600 | Carl Zeiss Meditec, AG | 2016-12-15 | 92 | 0 |
| K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | Icad, Inc. | 2016-02-25 | 73 | 0 |
| K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System | Sensus Healthcare | 2015-10-16 | 280 | 1 |
| K141343 | AXXENT CERVICAL APPLICATOR | Icad, Inc. | 2014-09-05 | 107 | 0 |
| K132092 | ESTEYA | Nucletron B.V. | 2013-09-26 | 83 | 0 |
| K131582 | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTE | Sensus Healthcare | 2013-08-28 | 89 | 0 |
| K130549 | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR | Carl Zeiss Meditec, Inc. | 2013-06-26 | 114 | 0 |
| K123985 | SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 | Sensus Healthcare | 2013-05-14 | 139 | 0 |
| K122951 | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 | Icad, Inc. | 2013-01-17 | 114 | 0 |
| K121653 | INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS | Carl Zeiss Meditec, Inc. | 2012-12-27 | 205 | 1 |
| K110590 | INTRABEAM NEEDLE APPLICATOR | Carl Zeiss Surgical GmbH | 2012-04-13 | 408 | 0 |
| K111299 | AXXENT RADIATION SHIELD - RIGID | Xoft, an Icad Company | 2011-07-20 | 72 | 0 |
| K090584 | INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS | Carl Zeiss Surgical GmbH | 2009-11-24 | 266 | 4 |
| K090914 | AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2 | Xoft, Inc. | 2009-07-16 | 106 | 0 |
| K083734 | AXXENT SURFACE APPLICATOR, MODEL 710257 | Xoft, Inc. | 2009-02-11 | 57 | 0 |
| K072616 | AXXENT VAGINAL APPLICATOR | Xoft, Inc. | 2008-05-09 | 235 | 0 |
| K072683 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | Xoft, Inc. | 2008-02-29 | 161 | 0 |
| K063456 | SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM | Topex, Inc. | 2007-01-09 | 55 | 0 |
| K050843 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | Xoft, Inc. | 2005-12-22 | 265 | 0 |
| K051055 | INTRABEAM SYSTEM | Carl Zeiss Surgical GmbH | 2005-05-23 | 27 | 1 |
| K992577 | PHOTON RADIOSURGERY SYSTEM (PRS) | Photoelectron Corporation | 1999-09-23 | 52 | 0 |
| K980526 | PHOTON RADIOSURGERY SYSTEM PRS400 | Pec Photoelectron Corp. | 1998-07-27 | 167 | 0 |
| K973315 | THERAPAX DXT 300 MODEL HF-300 | Pantak, Inc. | 1997-12-02 | 90 | 0 |
| K964952 | VERIDOSE V (FIVE), MODEL NUMBER 37-705 | Victoreen, Inc. | 1997-07-21 | 223 | 0 |
| K964947 | PHOTON RADIOSURGERY SYSTEM (PRS) | Photoelectron Corporation | 1997-06-20 | 192 | 0 |
| K971074 | THERAPAX SXT 150 | Pantak, Inc. | 1997-06-13 | 81 | 0 |
| K962613 | DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM | Gulmay Medical , Ltd. | 1996-09-27 | 86 | 0 |
| K935209 | INSTA-FLO | Medtec, Inc. | 1993-12-13 | 45 | 0 |
| K923584 | THERAPAX DXT 300 SERIES 3 | Oldelft Corp. of America | 1993-01-15 | 179 | 0 |
| K904005 | HUESTIS FLEXI-BOARD | Huestis Machine Corp. | 1990-11-29 | 92 | 0 |
| K903377 | COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION | Siemens Medical Solutions USA, Inc. | 1990-09-21 | 53 | 0 |
| K894683 | FABFOAM #302 | Jewell Industries | 1989-09-07 | 44 | 0 |
| K882484 | CMS RECORD AND VERIFY SYSTEM | Computerized Medical Systems, Inc. | 1988-12-21 | 189 | 0 |
| K874214 | S9 DISPLAY SYSTEM | O.M.I. Oncology Microsystems, Inc. | 1988-02-22 | 129 | 0 |
| K871810 | PLAN-32 SOFTWARE | Oncology Systems, Inc. | 1987-10-30 | 175 | 0 |
| K861431 | THERAPAX HT 150T | Old Delft Corp. of America | 1986-05-21 | 35 | 0 |
| K854609 | MEVAMATIC 3 | Siemens Medical Laboratories, Inc. | 1986-02-21 | 95 | 0 |
| K844424 | INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10 | Varian Assoc., Inc. | 1985-02-21 | 98 | 0 |
| K833560 | RTP-5100-5200-5300 & 5400 | Adac Laboratories | 1983-12-08 | 51 | 0 |
| K813439 | RTP-5000 | Adac Laboratories | 1982-01-22 | 45 | 0 |
| K811528 | RADIATION BOLUS | Action Products, Inc. | 1981-07-10 | 39 | 2 |
| K781084 | THERAPAX 150A | Emi Therapy Systems, Inc. | 1978-07-18 | 19 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda