Atlas FDA

JAI

32 FDA 510(k) clearances · Product code

77 daysmedian time to decision
274 days90th percentile
32clearances measured

FDA profile

Official device name
Couch, Radiation Therapy, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5770
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2001: 2 · 2002: 3 · 2004: 2 · 2006: 12 · 2007: 4 · 2009: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Eve Patient Positioner System (K231612)Leo Cancer Care2024-05-07
Z-Robot Patient Positioning System (K182683)Chinan Biomedical Technology, Inc.2019-06-27
Patient Positioning System (K170502)Forte Automation Systems, Inc.2017-04-13
LEONI ORION System (K160518)Leoni Cia Cable System2016-07-14
PROTURA COUCH SOFTWARE (K132084)Med-Tec, Inc. D/B/A Civco Medical Solutions2013-09-26
PATIENT POSITIONING SYSTEM (K122413)Forte Automation Systems, Inc.2012-09-13
PROTURA COUCH SOFTWARE (K122201)Med-Tec, Inc. D/B/A Civco Medical Solutions2012-08-30
EXACTRAC ROBOTICS NOVALIS ROBOTICS (K120520)Brainlab AG2012-06-29
QFIX RADIOTHERAPY CHAIR (K120916)Wfr/Aquaplast Corp.2012-06-20
HEXAPOD EVO RT COUCH TOP (K072898)Medical Intelligence Medizintechnik GmbH2007-10-25
HEXAPOD RT COUCH TOP (K071870)Medical Intelligence Medizintechnik GmbH2007-07-08
MODIFICATION TO HEXAPOD RT COUCH TOP (K062639)Medical Intelligence Medizintechnik-GmbH-An Elekta2006-09-21
AVANZA (K060870)Mds Nordion2006-05-15
KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS (K060671)Wfr/Aquaplast Corp.2006-05-04
550 TXT TREATMENT TABLE (K050422)Siemens Medical Solutions USA, Inc.2005-03-18
ROBOCOUCH PATIENT SUPPORT SYSTEM (K042146)Accuray Incorporated2004-09-17
HEXAPOD RT COUCHTOP (K041448)Medical Intelligence Medizintechnik GmbH2004-06-16
TABLE TILT DEVICE (K033316)Brainlab AG2004-05-14
PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 (K034054)Med-Tec,Inc.2004-02-20
MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC (K031866)Med-Tec,Inc.2003-08-14
NOMOS MOTORIZED CRANE II (K013036)Nomos Corp.2001-12-07
AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT (K993522)Aktina Medical Physics Corp.2000-01-10
ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE (K983678)Elekta Instruments, Inc.1999-01-15
DYNAMIC SHIELDING RADIATION TABLE (K982446)American Biophysics, Inc.1998-09-29
THE NOMOS MINICRANE (K964740)Nomos Corp.1997-02-11
THE NOMOS CRANE (K941927)Nomos Corp.1995-02-09
GENESYS AND THE ROI (K910002)The Complete Systems Corp. Genesys1991-07-22
THERAPY CHAIR SYSTEM (K910648)Radiation Technology, Inc.1991-07-22
Z XT RADIATION THERAPY TREATMENT TABLE (K910971)Siemens Medical Laboratories, Inc.1991-05-03
UNIVERSAL PATIENT CHAIR UNI 2000X (K855063)Siemens Medical Solutions USA, Inc.1986-01-30
TCT-1 TREATMENT COUCH (K834201)Therados, Inc.1984-03-05
THERAC 25 LINEAR ACCELERATOR (K837152)Atomic Energy of Canada1983-03-22

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