Atlas FDA

JAD

53 FDA 510(k) clearances · Product code

95 daysmedian time to decision
259 days90th percentile
53clearances measured

FDA profile

Official device name
System, Therapeutic, X-Ray
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5900
Medical specialty
Radiology
Adverse events (MAUDE)
2001: 1 · 2002: 1 · 2003: 3 · 2007: 2 · 2009: 5 · 2013: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
GentleBeam (GB1000) (K250692)Voxel Ray Solutions, LLC2025-12-03
INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) (K241174)Carl Zeiss Meditec, AG2025-01-10
X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) (K230611)Xstrahl, Ltd.2023-07-13
Esteya (K213942)Nucletron B.V.2022-01-11
Sensus Healthcare TVM Balloon Applicator (K190255)Sensus Healthcare, Inc.2019-02-21
Sensus IORT System (K182641)Sensus Healthcare, Inc.2019-02-21
SRT-100+ (K173425)Sensus Healthcare, Inc.2018-03-23
Photoelectric Therapy System (K172080)Xstrahl, Ltd.2017-09-29
INTRABEAM 600 (K162568)Carl Zeiss Meditec, AG2016-12-15
Axxent Electronic Brachytherapy System Model 110 XP 1200 (K153570)Icad, Inc.2016-02-25
Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities (K150037)Sensus Healthcare2015-10-16
AXXENT CERVICAL APPLICATOR (K141343)Icad, Inc.2014-09-05
ESTEYA (K132092)Nucletron B.V.2013-09-26
SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM (K131582)Sensus Healthcare2013-08-28
INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR (K130549)Carl Zeiss Meditec, Inc.2013-06-26
SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 (K123985)Sensus Healthcare2013-05-14
XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 (K122951)Icad, Inc.2013-01-17
INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS (K121653)Carl Zeiss Meditec, Inc.2012-12-27
INTRABEAM NEEDLE APPLICATOR (K110590)Carl Zeiss Surgical GmbH2012-04-13
AXXENT RADIATION SHIELD - RIGID (K111299)Xoft, an Icad Company2011-07-20
INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS (K090584)Carl Zeiss Surgical GmbH2009-11-24
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E (K090914)Xoft, Inc.2009-07-16
AXXENT SURFACE APPLICATOR, MODEL 710257 (K083734)Xoft, Inc.2009-02-11
AXXENT VAGINAL APPLICATOR (K072616)Xoft, Inc.2008-05-09
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM (K072683)Xoft, Inc.2008-02-29
SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM (K063456)Topex, Inc.2007-01-09
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM (K050843)Xoft, Inc.2005-12-22
INTRABEAM SYSTEM (K051055)Carl Zeiss Surgical GmbH2005-05-23
PHOTON RADIOSURGERY SYSTEM (PRS) (K992577)Photoelectron Corporation1999-09-23
PHOTON RADIOSURGERY SYSTEM PRS400 (K980526)Pec Photoelectron Corp.1998-07-27
THERAPAX DXT 300 MODEL HF-300 (K973315)Pantak, Inc.1997-12-02
VERIDOSE V (FIVE), MODEL NUMBER 37-705 (K964952)Victoreen, Inc.1997-07-21
PHOTON RADIOSURGERY SYSTEM (PRS) (K964947)Photoelectron Corporation1997-06-20
THERAPAX SXT 150 (K971074)Pantak, Inc.1997-06-13
DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM (K962613)Gulmay Medical , Ltd.1996-09-27
INSTA-FLO (K935209)Medtec, Inc.1993-12-13
THERAPAX DXT 300 SERIES 3 (K923584)Oldelft Corp. of America1993-01-15
HUESTIS FLEXI-BOARD (K904005)Huestis Machine Corp.1990-11-29
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION (K903377)Siemens Medical Solutions USA, Inc.1990-09-21
FABFOAM #302 (K894683)Jewell Industries1989-09-07
CMS RECORD AND VERIFY SYSTEM (K882484)Computerized Medical Systems, Inc.1988-12-21
S9 DISPLAY SYSTEM (K874214)O.M.I. Oncology Microsystems, Inc.1988-02-22
PLAN-32 SOFTWARE (K871810)Oncology Systems, Inc.1987-10-30
THERAPAX HT 150T (K861431)Old Delft Corp. of America1986-05-21
MEVAMATIC 3 (K854609)Siemens Medical Laboratories, Inc.1986-02-21
INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10 (K844424)Varian Assoc., Inc.1985-02-21
RTP-5100-5200-5300 & 5400 (K833560)Adac Laboratories1983-12-08
RTP-5000 (K813439)Adac Laboratories1982-01-22
RADIATION BOLUS (K811528)Action Products, Inc.1981-07-10
THERAPAX 150A (K781084)Emi Therapy Systems, Inc.1978-07-18
RADIATION THERAPY TREAT. PLAN. SYS. (K780278)Pfizer Medical Systems, Inc.1978-03-02
RADIATION TREATMENT PLANNING SYSTEM (K780157)Capintec, Inc.1978-02-13
EMI THERAPY SIMULATOR (K771817)Emi Therapy Systems, Inc.1978-01-13

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Every clearance here is in the API, with alerts when new ones post.