Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

IXI · Predicate Candidate Screening

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

90 daysmedian FDA review time

196 days90th percentile

51clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253025	Ricoh 3D for Healthcare Bolus	Ricoh 3D For Healthcare, LLC	2026-04-06	199	0
K222639	VHA Radiotherapy Bolus	Vha Dean	2022-11-04	64	0
K214093	VSP Bolus	3D Systems	2022-03-30	92	0
K132236	.DECIMAL PROTON APERTURE	.Decimal, Inc.	2013-10-16	90	0
K131150	CURA COMPENSATOR	Cura Medical Technologies, LLC	2013-07-30	98	0
K123893	CURA COLLIMATOR	Cura Medical Technologies, LLC	2013-03-04	76	0
K123015	.DECIMAL PHOTON BLOCK	.Decimal, Inc.	2012-11-21	54	0
K111676	APEX	Elekta Limited	2011-09-30	107	1
K111759	.DECIMAL ELECTRON APERTURE	.Decimal, Inc.	2011-09-09	79	0
K091403	MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY	Oncology Tech, LLC	2009-07-29	78	0
K091911	BOLUS COMPENSATOR	.Decimal, Inc.	2009-07-21	26	0
K090417	AXXENT FLEXISHIELD MINI	Xoft, Inc.	2009-06-23	125	1
K071078	.DECIMAL RANGE COMPENSATOR	.Decimal, Inc.	2007-05-22	35	0
K071077	.DECIMAL APERTURE	.Decimal, Inc.	2007-05-18	31	0
K062781	MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY	Symtium Corporation	2006-11-21	64	0
K060187	TOPSLANE DMLC	Topslane International, LLC	2006-07-27	184	0
K052383	INNOCURE IMRT FILTER (COMPENSATORS)	Innocure, LLC	2006-03-29	211	0
K040804	.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR	Southeastern Radiation Products, Inc.	2004-04-28	30	0
K040553	MODIFICATION TO ACCULEAF	Direx Systems Corp.	2004-04-01	30	0
K032790	MICROMLC	Siemens Medical Solutions USA, Inc.	2003-10-02	24	0
K030609	MODULEAF	Mrc Systems GmbH	2003-03-17	19	1
K021987	PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY	S&S Par Scientific	2002-12-27	192	0
K013875	MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE	Med-Tec,Inc.	2002-09-27	308	0
K011816	MINI MULTILEAF COLLIMATOR, MODEL KMI	Mrc Systems GmbH	2001-09-07	88	0
K010172	LEAD BLOCKS	Arplay Medical S.A.	2001-04-18	90	0
K001163	DMLC IV-ERGO	3D Line USA, Inc.	2000-10-23	196	2
K000349	MOTORIZED MICRO MULTILEAF COLLIMATOR	Stryker Leibinger	2000-05-03	90	0
K000137	ENHANCED COMPENSATING FILTER	Computerized Medical Systems, Inc.	2000-04-17	90	0
K990491	ANGIO-CT MIYABI	Siemens Medical Solutions USA, Inc.	1999-04-05	47	0
K981992	ELECTRON WEDGE MODEL MT-EW-1000	Med-Tec,Inc.	1998-12-15	190	0
K974239	AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYST	Aktina Medical Physics Corp.	1998-02-10	90	0
K973953	AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPIN	Aktina Medical Physics Corp.	1998-01-14	90	0
K972016	AUTIMO 2.5-D AND AUTIMO 3-D	C.L. Mcintosh & Assoc., Inc.	1997-12-04	188	0
K971001	AUTIMO	Medizintechnik, GmbH	1997-06-13	86	0
K970303	SATURNE MULTILEAF COLLIMATOR	General Electric Co.	1997-04-25	88	0
K961902	SIEMENS BEAM SHAPER	Siemens Medical Solutions USA, Inc.	1996-08-08	84	0
K954248	SIEMENS VIRTURAL WEDGE	Siemens Medical Solutions USA, Inc.	1996-01-05	116	0
K953227	CASPER	Northwest Medical Physics Center	1995-11-22	140	0
K953894	SIEMENS MULTILEAF COLLIMATOR	Siemens Medical Solutions USA, Inc.	1995-11-13	88	0
K940412	MULTILEAF INTENSITY MODULATING COLLIMATOR	Nomos Corp.	1995-02-15	384	0
K943343	FIELD ABUTMENT WEDGE	Medtec, Inc.	1994-12-23	164	0
K941719	360 DEG. ROTATING 1/2 BEAM BLOCK	Medtec, Inc.	1994-07-18	102	0
K904124	PHILIPS MULTILEAF COLLIMATOR (MLC)	Philips Medical Systems, Inc.	1991-01-30	146	0
K901567	THE HUESTIS COMPU-PLOTTER	Huestis Machine Corp.	1990-05-31	58	0
K893464	VARIAN MULTILEAF COLLIMATOR	Varian Assoc., Inc.	1989-08-10	99	0
K883317	DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST	S & S X-Ray Products, Inc.	1989-04-26	264	0
K880047	HUESTIS COMPU-FORMER	Huestis Machine Corp.	1988-04-11	96	0
K860193	PORTALCAST	Diacor, Inc.	1986-01-30	8	0
K852353	DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM	Thomson-Cgr Medical Corp.	1985-08-07	65	0
K842615	CLARK PRECISION BLOCK CUTTER, COOLING	Clark Research and Development, Inc.	1984-09-04	61	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