Product Code: IXW FDA class 2 21 CFR 892.1900

Processor, Radiographic-Film, Automatic

Radiology

An automatic radiographic film processor is a device that mechanically transports radiographic film through chemical developer, fixer, wash, and drying stages to produce a developed radiographic image, replacing manual darkroom processing. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IXW, regulated under 21 CFR 892.1900, within the Radiology medical specialty.

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FEI Numbers

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Unique Applicants

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Basic Information

Product Code: IXW
Device Class: FDA class 2
Regulation Number: 892.1900
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 83 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K111167	XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT	Aug 18, 2011	Substantially Equivalent	Velopex International, Inc.
K093503	INTRAX FILM PROCESSOR	Jan 06, 2010	Substantially Equivalent	Velopex International, Inc.
K091628	OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX	Aug 21, 2009	Substantially Equivalent	Protec GmbH & Co. KG
K024342	RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000	Apr 23, 2003	Substantially Equivalent	Daito Co., Ltd.
K023825	FILM PROCESSOR, MODEL LIFE RAY PRO 2500	Feb 12, 2003	Substantially Equivalent	S.A.I.E.P. S.R.L.
K023801	FILM PROCESSOR, MODEL LIFE RAY PRO 1000	Feb 12, 2003	Substantially Equivalent	S.A.I.E.P. S.R.L.
K023613	AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036	Jan 23, 2003	Substantially Equivalent	Alphatek Corp.
K022154	LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D	Sep 30, 2002	Substantially Equivalent	Fischer Industries, Inc.
K002640	FREEDOM AUTOMATIC FILM PROCESSOR	Nov 08, 2000	Substantially Equivalent	J. Morita USA, Inc.
K002404	MICRO-MAX, MODEL 319	Aug 30, 2000	Substantially Equivalent	Tek Marketing, Inc.
K001321	ALL-PRO 2010	May 16, 2000	Substantially Equivalent	All-Pro Imaging Corp.
K992818	OPTIMAX/ COMPACT 2	Sep 01, 1999	Substantially Equivalent	Protec GmbH & Co. KG
K990969	KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR	Jun 18, 1999	Substantially Equivalent	Konica Medical Corp.
K991435	AII-PRO 100 PLUS AND ALL-PRO 200	May 20, 1999	Substantially Equivalent	All-Pro Imaging Corp.
K981280	CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS	Apr 30, 1998	Substantially Equivalent	Bayer Corp., Agfa Div.
K973125	MAMMOLOADER BY C.M.A. SRL	Oct 08, 1997	Substantially Equivalent	C.M.A.
K970059	KODAK MINILOADER(2000)	Jan 27, 1997	Substantially Equivalent	Eastman Kodak Company
K962750	3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR	Aug 21, 1996	Substantially Equivalent	Imation Corp.
K955706	JPI AUTOMATIC X-RAY FILM PROCESSOR	Feb 12, 1996	Substantially Equivalent	Jpi Healthcare Co, Ltd.
K951373	FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ	Oct 27, 1995	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K954484	KODAK AUTOMIXER II PLUS	Oct 18, 1995	Substantially Equivalent	Eastman Kodak Company
K954345	DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR	Oct 18, 1995	Substantially Equivalent	Doosan Corp.
K951397	KODAK X-OMAT 5000 RA PROCESSOR	May 15, 1995	Substantially Equivalent	Eastman Kodak Company
K951396	KODAK X-OMAT 3000 RA PROCESSOR	May 15, 1995	Substantially Equivalent	Eastman Kodak Company
K944046	FUJI COMPUTED RADIOGRAPHY SYSTEMS	May 11, 1995	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K950043	JPI AUTOMATIC X-RAY FILM PROCESSOR	May 10, 1995	Substantially Equivalent	Jpi Healthcare Co, Ltd.
K940112	X-RAY FILM PROCESSOR	Apr 11, 1995	Substantially Equivalent	Fischer Industries, Inc.
K950358	KONICA SRX-201 AUTOMATIC X-RA FILM PROCESSOR	Mar 17, 1995	Substantially Equivalent	Storch Amini & Munves PC
K940540	VELO ACE	Jul 18, 1994	Substantially Equivalent	Emix U.S.A., Inc.
K940558	3M XP-2000 X-RAY FILM PROCESSOR	Mar 22, 1994	Substantially Equivalent	3M Company
K934350	KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS	Mar 21, 1994	Substantially Equivalent	Eastman Kodak Company
K935957	FUJI MEDICAL FILM PROCESSOR FPM2800	Jan 31, 1994	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K931317	KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR	Dec 14, 1993	Substantially Equivalent	Konica Medical Corp.
K931316	KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR	Dec 14, 1993	Substantially Equivalent	Konica Medical Corp.
K931315	KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR	Dec 14, 1993	Substantially Equivalent	Konica Medical Corp.
K933001	KODAK XML 300 DARKROOM FILM FEEDER	Sep 28, 1993	Substantially Equivalent	Eastman Kodak Company
K931314	KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR	Sep 07, 1993	Substantially Equivalent	Konica Medical Corp.
K931313	KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR	Sep 07, 1993	Substantially Equivalent	Konica Medical Corp.
K931312	KONICA SRX-101 AUTOMATIC X-RAY FILM PROCESSOR	Sep 07, 1993	Substantially Equivalent	Konica Medical Corp.
K931883	AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033	Aug 23, 1993	Substantially Equivalent	Alphatek Corp.
K931882	MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR	Aug 23, 1993	Substantially Equivalent	Alphatek Corp.
K933408	FUJI DAYLIGHT CASSETTE MULTI-LOADER	Aug 16, 1993	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K925885	AFP 17 X 4 AUTOMATIC FILM PROCESSOR	Jun 09, 1993	Substantially Equivalent	Afp Imaging Corp.
K923554	KODAK EKTASCAN	Feb 12, 1993	Substantially Equivalent	Eastman Kodak Company
K925569	AX-700LE AUTOMATIC X-RAY FILM PROCESSOR	Jan 15, 1993	Substantially Equivalent	Alphatek Corp.
K924552	DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)	Dec 07, 1992	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K924430	AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027	Nov 27, 1992	Substantially Equivalent	Alphatek Corp.
K923552	KODAK X-OMAT FS-1A PROCESSOR	Nov 27, 1992	Substantially Equivalent	Eastman Kodak Company
K921269	KODAK X-OMAT MODEL 180 LP PROCESSOR	May 01, 1992	Substantially Equivalent	Eastman Kodak Company
K920715	KODAK X-OMAT FIXER MANAGER	Apr 27, 1992	Substantially Equivalent	Eastman Kodak Company
K914143	KODAK X-OMAT 480 RA PROCESSOR	Jan 06, 1992	Substantially Equivalent	Eastman Kodak Company
K913354	KODAK EKTASCAN STORAGE PHOSPHOR READER MODEL 1A	Sep 04, 1991	Substantially Equivalent	Eastman Kodak Company
K912225	3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT	Jul 22, 1991	Substantially Equivalent	3M Medical Products Group
K911291	ALL-PRO 100	Jul 03, 1991	Substantially Equivalent	All-Pro Imaging Corp.
K911714	KODAK M35-MX-0MAT PROCESSOR	Jun 07, 1991	Substantially Equivalent	Eastman Kodak Company
K911713	KODAK 100-J & 100-K CHEMICAL MIXERS	Jun 07, 1991	Substantially Equivalent	Eastman Kodak Company
K911711	KODAK AUTOMATIC FILM FEEDER, MODEL RA	Jun 07, 1991	Substantially Equivalent	Eastman Kodak Company
K905607	KODAK X-OMAT MULTILOADER 300	Mar 12, 1991	Substantially Equivalent	Eastman Kodak Company
K904238	KODAK X-MAT 270 RA PROCESSOR	Oct 03, 1990	Substantially Equivalent	Eastman Kodak Company
K902732	KODAK X-OMAT 460 RA PROCESSOR	Aug 17, 1990	Substantially Equivalent	Eastman Kodak Company
K901772	KODAK M35A-M X-OMAT PROCESSOR	Jul 25, 1990	Substantially Equivalent	Eastman Kodak Company
K890486	MXR-14 FILM PROCESSOR	Apr 03, 1990	Substantially Equivalent	Cordell, Inc.
K885207	KODAK MULTILOADER 700	Mar 14, 1989	Substantially Equivalent	Eastman Kodak Company
K882320	KODAK EKTASCAN LASER PRINTER ADAPTER, MODEL M6/M8	Jun 16, 1988	Substantially Equivalent	Eastman Kodak Company
K881248	KODAK AUTOMATIC FILM FEEDER, MODEL 11	Apr 12, 1988	Substantially Equivalent	Eastman Kodak Company
K880565	3M TRIMATIC M MODULAR SYSTEM AND ACCESSORIES	Mar 21, 1988	Substantially Equivalent	3M Company
K880564	3M XP 505 X-RAY FILM PROCESSOR	Mar 21, 1988	Substantially Equivalent	3M Company
K880563	3M XP515 X-RAY FILM PROCESSOR	Mar 21, 1988	Substantially Equivalent	3M Company
K874908	C900 X-RAY FILM PROCESSOR	Feb 12, 1988	Substantially Equivalent	Summit Industries, Inc.
K874926	KODAK REMOTE ALARM UNIT	Jan 04, 1988	Substantially Equivalent	Eastman Kodak Company
K862595	KODAK M35A X-OMAT PROCESSOR	Jul 11, 1986	Substantially Equivalent	Eastman Kodak Company
K861225	KODAK AUTOMIXER II	Apr 07, 1986	Substantially Equivalent	Eastman Kodak Company
K860666	KODAK X-OMAT PROCESSOR, MODEL ME-3	Mar 06, 1986	Substantially Equivalent	Eastman Kodak Company
K855219	KODAK RP X-OMAT PROCESSOR MODEL M6B	Jan 10, 1986	Substantially Equivalent	Eastman Kodak Company
K854219	KODAK M35 X-OMAT PROCESSOR	Jan 01, 1986	Substantially Equivalent	Eastman Kodak Company
K832603	CURIX CAPACITY FILM CENTER	Sep 29, 1983	Substantially Equivalent	Agfa-Gevaert, Inc.
K812088	POLAROID RADIOGRAPHIC FILM PROCESSOR	Aug 31, 1981	Substantially Equivalent	Polaroid Corp.
K801209	KODAK MEDICAL X-RAY DEVELOPER & REPLEN.	Jun 26, 1980	Substantially Equivalent	Eastman Kodak Company
K790121	FILM-X 90	Feb 21, 1979	Substantially Equivalent	Automatic Film Processor Corp.
K781934	PROCESSOR, MODEL M8	Dec 04, 1978	Substantially Equivalent	Eastman Kodak Company
K780248	CRONEX QC-1 PROCESSOR	Mar 02, 1978	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K771857	AUTOMIXER, KODAK	Oct 19, 1977	Substantially Equivalent	Eastman Kodak Company
K760905	SUPERMAX AUTOMATIC X-RAY PROCESSOR	Nov 19, 1976	Substantially Equivalent	General Electric Co.