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

IXW — Predicate Candidate Screening

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

59 daysmedian FDA review time

205 days90th percentile

83clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K111167	XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER	Velopex International, Inc.	2011-08-18	114	0
K093503	INTRAX FILM PROCESSOR	Velopex International, Inc.	2010-01-06	55	0
K091628	OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX	Protec GmbH & Co. KG	2009-08-21	78	0
K024342	RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000	Daito Co., Ltd.	2003-04-23	117	0
K023825	FILM PROCESSOR, MODEL LIFE RAY PRO 2500	S.A.I.E.P. S.R.L.	2003-02-12	90	0
K023801	FILM PROCESSOR, MODEL LIFE RAY PRO 1000	S.A.I.E.P. S.R.L.	2003-02-12	90	0
K023613	AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036	Alphatek Corp.	2003-01-23	87	0
K022154	LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D	Fischer Industries, Inc.	2002-09-30	90	0
K002640	FREEDOM AUTOMATIC FILM PROCESSOR	J. Morita USA, Inc.	2000-11-08	76	0
K002404	MICRO-MAX, MODEL 319	Tek Marketing, Inc.	2000-08-30	23	0
K001321	ALL-PRO 2010	All-Pro Imaging Corp.	2000-05-16	20	0
K992818	OPTIMAX/ COMPACT 2	Protec GmbH & Co. KG	1999-09-01	12	0
K990969	KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR	Konica Medical Corp.	1999-06-18	87	0
K991435	AII-PRO 100 PLUS AND ALL-PRO 200	All-Pro Imaging Corp.	1999-05-20	24	0
K981280	CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY	Bayer Corp., Agfa Div.	1998-04-30	22	0
K973125	MAMMOLOADER BY C.M.A. SRL	C.M.A.	1997-10-08	49	0
K970059	KODAK MINILOADER(2000)	Eastman Kodak Company	1997-01-27	20	0
K962750	3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AU	Imation Corp.	1996-08-21	37	0
K955706	JPI AUTOMATIC X-RAY FILM PROCESSOR	Jpi Healthcare Co, Ltd.	1996-02-12	59	0
K951373	FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ	Fujifilm Medical System U.S.A., Inc.	1995-10-27	214	0
K954484	KODAK AUTOMIXER II PLUS	Eastman Kodak Company	1995-10-18	21	0
K954345	DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR	Doosan Corp.	1995-10-18	30	0
K951396	KODAK X-OMAT 3000 RA PROCESSOR	Eastman Kodak Company	1995-05-15	49	0
K951397	KODAK X-OMAT 5000 RA PROCESSOR	Eastman Kodak Company	1995-05-15	49	0
K944046	FUJI COMPUTED RADIOGRAPHY SYSTEMS	Fujifilm Medical System U.S.A., Inc.	1995-05-11	266	0
K950043	JPI AUTOMATIC X-RAY FILM PROCESSOR	Jpi Healthcare Co, Ltd.	1995-05-10	125	0
K940112	X-RAY FILM PROCESSOR	Fischer Industries, Inc.	1995-04-11	456	0
K950358	KONICA SRX-201 AUTOMATIC X-RA FILM PROCESSOR	Storch Amini & Munves PC	1995-03-17	49	0
K940540	VELO ACE	Emix U.S.A., Inc.	1994-07-18	161	0
K940558	3M XP-2000 X-RAY FILM PROCESSOR	3M Company	1994-03-22	43	0
K934350	KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS	Eastman Kodak Company	1994-03-21	195	0
K935957	FUJI MEDICAL FILM PROCESSOR FPM2800	Fujifilm Medical System U.S.A., Inc.	1994-01-31	49	0
K931317	KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR	Konica Medical Corp.	1993-12-14	274	0
K931315	KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR	Konica Medical Corp.	1993-12-14	274	0
K931316	KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR	Konica Medical Corp.	1993-12-14	274	0
K933001	KODAK XML 300 DARKROOM FILM FEEDER	Eastman Kodak Company	1993-09-28	99	0
K931314	KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR	Konica Medical Corp.	1993-09-07	176	0
K931312	KONICA SRX-101 AUTOMATIC X-RAY FILM PROCESSOR	Konica Medical Corp.	1993-09-07	176	0
K931313	KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR	Konica Medical Corp.	1993-09-07	176	0
K931882	MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR	Alphatek Corp.	1993-08-23	131	0
K931883	AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033	Alphatek Corp.	1993-08-23	131	0
K933408	FUJI DAYLIGHT CASSETTE MULTI-LOADER	Fujifilm Medical System U.S.A., Inc.	1993-08-16	35	0
K925885	AFP 17 X 4 AUTOMATIC FILM PROCESSOR	Afp Imaging Corp.	1993-06-09	205	0
K923554	KODAK EKTASCAN	Eastman Kodak Company	1993-02-12	210	1
K925569	AX-700LE AUTOMATIC X-RAY FILM PROCESSOR	Alphatek Corp.	1993-01-15	73	0
K924552	DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)	E.I. Dupont DE Nemours & Co., Inc.	1992-12-07	89	0
K924430	AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027	Alphatek Corp.	1992-11-27	87	0
K923552	KODAK X-OMAT FS-1A PROCESSOR	Eastman Kodak Company	1992-11-27	133	0
K921269	KODAK X-OMAT MODEL 180 LP PROCESSOR	Eastman Kodak Company	1992-05-01	45	0
K920715	KODAK X-OMAT FIXER MANAGER	Eastman Kodak Company	1992-04-27	69	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