Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

JAI — Predicate Candidate Screening

32 FDA 510(k) clearances under this product code; the 50 most recent screened below.

77 daysmedian FDA review time

274 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K231612	Eve Patient Positioner System	Leo Cancer Care	2024-05-07	340	0
K182683	Z-Robot Patient Positioning System	Chinan Biomedical Technology, Inc.	2019-06-27	274	0
K170502	Patient Positioning System	Forte Automation Systems, Inc.	2017-04-13	51	0
K160518	LEONI ORION System	Leoni Cia Cable System	2016-07-14	141	2
K132084	PROTURA COUCH SOFTWARE	Med-Tec, Inc. D/B/A Civco Medical Solutions	2013-09-26	83	0
K122413	PATIENT POSITIONING SYSTEM	Forte Automation Systems, Inc.	2012-09-13	36	0
K122201	PROTURA COUCH SOFTWARE	Med-Tec, Inc. D/B/A Civco Medical Solutions	2012-08-30	36	0
K120520	EXACTRAC ROBOTICS NOVALIS ROBOTICS	Brainlab AG	2012-06-29	129	0
K120916	QFIX RADIOTHERAPY CHAIR	Wfr/Aquaplast Corp.	2012-06-20	85	0
K072898	HEXAPOD EVO RT COUCH TOP	Medical Intelligence Medizintechnik GmbH	2007-10-25	14	1
K071870	HEXAPOD RT COUCH TOP	Medical Intelligence Medizintechnik GmbH	2007-07-08	2	0
K062639	MODIFICATION TO HEXAPOD RT COUCH TOP	Medical Intelligence Medizintechnik-GmbH-An Elekta	2006-09-21	15	0
K060870	AVANZA	Mds Nordion	2006-05-15	46	0
K060671	KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND A	Wfr/Aquaplast Corp.	2006-05-04	51	0
K050422	550 TXT TREATMENT TABLE	Siemens Medical Solutions USA, Inc.	2005-03-18	28	3
K042146	ROBOCOUCH PATIENT SUPPORT SYSTEM	Accuray Incorporated	2004-09-17	39	3
K041448	HEXAPOD RT COUCHTOP	Medical Intelligence Medizintechnik GmbH	2004-06-16	15	0
K033316	TABLE TILT DEVICE	Brainlab AG	2004-05-14	212	1
K034054	PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100	Med-Tec,Inc.	2004-02-20	52	0
K031866	MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC	Med-Tec,Inc.	2003-08-14	59	0
K013036	NOMOS MOTORIZED CRANE II	Nomos Corp.	2001-12-07	88	0
K993522	AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT	Aktina Medical Physics Corp.	2000-01-10	84	0
K983678	ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE	Elekta Instruments, Inc.	1999-01-15	87	4
K982446	DYNAMIC SHIELDING RADIATION TABLE	American Biophysics, Inc.	1998-09-29	76	0
K964740	THE NOMOS MINICRANE	Nomos Corp.	1997-02-11	77	0
K941927	THE NOMOS CRANE	Nomos Corp.	1995-02-09	295	0
K910002	GENESYS AND THE ROI	The Complete Systems Corp. Genesys	1991-07-22	201	0
K910648	THERAPY CHAIR SYSTEM	Radiation Technology, Inc.	1991-07-22	158	0
K910971	Z XT RADIATION THERAPY TREATMENT TABLE	Siemens Medical Laboratories, Inc.	1991-05-03	57	0
K855063	UNIVERSAL PATIENT CHAIR UNI 2000X	Siemens Medical Solutions USA, Inc.	1986-01-30	43	0
K834201	TCT-1 TREATMENT COUCH	Therados, Inc.	1984-03-05	91	0
K837152	THERAC 25 LINEAR ACCELERATOR	Atomic Energy of Canada	1983-03-22	387	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