Product Code: LMC FDA class 2 21 CFR 892.2040

Camera, Multi Format, Radiological

Radiology

Camera, Multi Format, Radiological is a device used to record radiological images in multiple photographic formats onto film from video displays or image intensifiers, used for documentation and archiving of diagnostic images from fluoroscopy, nuclear medicine, or other imaging modalities. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LMC, regulated under 21 CFR 892.2040, within the Radiology medical specialty. No special flags apply to this device.

View on FDA

510(k)s

121

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: LMC
Device Class: FDA class 2
Regulation Number: 892.2040
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 121 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K141454	SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD	Jun 26, 2014	Substantially Equivalent	Sony Electronics, Inc.
K141346	SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD	Jun 26, 2014	Substantially Equivalent	Sony Electronics, Inc.
K111566	DRYVIEW CHROMA IMAGING SYSTEM	Oct 06, 2011	Substantially Equivalent	Carestream Health, Inc.
K092280	CYPHER DICOM PRINT SOLUTION	Oct 16, 2009	Substantially Equivalent	Virtual Imaging, Inc.
K090469	CARESTREAM DRYVIEW 5850 LASER IMAGER	May 22, 2009	Substantially Equivalent	Carestream Health, Inc.
K083522	SONY UP-DF750 DIGITAL FILM IMAGER	Jan 09, 2009	Substantially Equivalent	Sony Electronics, Inc.
K081637	LASER IMAGER DRYPRO MODEL 873	Jul 01, 2008	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K072680	DRYSTAR AXYS, MODEL EYZ4E	Oct 25, 2007	Substantially Equivalent	Agfa Healthcare Corporation
K061999	DRY LASER IMAGER, DRYPRO MODEL 832	Aug 15, 2006	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K061302	DIGITAL PRINTER P6000D SERIES, MODEL P6000DU	Jun 23, 2006	Substantially Equivalent	Mitsubishi Electric Corporation Kyoto Works
K060440	CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER	Mar 16, 2006	Substantially Equivalent	Codonics, Inc.
K052251	DRYSTAR MODEL 5500	Aug 31, 2005	Substantially Equivalent	Agfa Corporation
K042133	DRY LASER IMAGER, MODEL DRYPRO MODEL 793	Nov 24, 2004	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K042232	NP-2600 SERIES HARDCOPY PRINTERS	Oct 05, 2004	Substantially Equivalent	Codonics, Inc.
K042159	KODAK COLOR MEDICAL IMAGER 1000	Sep 24, 2004	Substantially Equivalent	Eastman Kodak Company
K042158	KODAK MEDICAL IMAGER 300	Sep 24, 2004	Substantially Equivalent	Eastman Kodak Company
K033821	KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY	Feb 20, 2004	Substantially Equivalent	Eastman Kodak Company
K033377	FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L	Jan 09, 2004	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K032681	KONICA LASER IMAGER, MODEL DRYPRO MODEL 771	Sep 24, 2003	Substantially Equivalent	Konica Medical and Graphic Corporation
K032635	DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300	Sep 24, 2003	Substantially Equivalent	Agfa Corp.
K030690	CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS	Apr 30, 2003	Substantially Equivalent	Codonics, Inc.
K024188	UP-DF500 FILMSTATION DIGITAL FILM IMAGER	Feb 04, 2003	Substantially Equivalent	Sony Medical Systems
K023287	DRYSTAR 5500	Oct 22, 2002	Substantially Equivalent	Agfa Corp.
K022658	LR DICOM CONTROLLER	Sep 06, 2002	Substantially Equivalent	Agfa Corp.
K021054	CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER	May 09, 2002	Substantially Equivalent	Codonics, Inc.
K013052	KONICA LASER IMAGER, DRYPRO MODEL 751/752	Jan 16, 2002	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K012941	DRYSTAR, MODEL 4500M	Nov 29, 2001	Substantially Equivalent	Agfa Corp.
K012010	MODIFICATION TO LR 5200 FILM RECORDER	Sep 20, 2001	Substantially Equivalent	Agfa Corp.
K011949	ELK LASER IMAGER, MODEL EL-DRY 4000	Aug 29, 2001	Substantially Equivalent	Nishimoto Sangyo Co., Ltd.
K011617	LIFEJET PRINTER 400	Jun 08, 2001	Substantially Equivalent	Ferrania S.P.A. Stabilimento DI Ferrania
K010275	DRYSTAR 4500 PRINTER, MODEL 4500	Apr 27, 2001	Substantially Equivalent	Agfa Medical Imaging
K003481	CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660	Jan 19, 2001	Substantially Equivalent	Codonics, Inc.
K002146	KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY	Sep 27, 2000	Substantially Equivalent	Eastman Kodak Company
K992586	KONICA LASER IMAGER, DRYPRO MODEL 722	Oct 29, 1999	Substantially Equivalent	Konica Corp.
K991282	COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES	Jun 30, 1999	Substantially Equivalent	Seiko Instruments USA, Inc.
K983905	KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600	Jan 25, 1999	Substantially Equivalent	Eastman Kodak Company
K972822	IMATION SE-204 LASER IMAGER	Nov 19, 1997	Substantially Equivalent	Imation Enterprises Corp.
K972660	RAVEN DRY PRINTER	Nov 10, 1997	Substantially Equivalent	Sterling Diagnostic Imaging, Inc.
K973422	LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])	Oct 28, 1997	Substantially Equivalent	Dejarnette Research Systems
K973028	HELIOS LASER IMAGER 1417	Oct 28, 1997	Substantially Equivalent	Sterling Diagnostic Imaging, Inc.
K972847	KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)	Oct 07, 1997	Substantially Equivalent	Eastman Kodak Company
K971760	COLORPOINT OR PROFESSIONAL COLORPOINT	Oct 01, 1997	Substantially Equivalent	Seiko Instruments USA, Inc.
K972163	IMATION SE-196 LASER IMAGER	Sep 05, 1997	Substantially Equivalent	Imation Corp.
K964414	LR 5200 LASER FILM RECORDER	Jan 27, 1997	Substantially Equivalent	Bayer Corp., Agfa Div.
K962364	CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)	Nov 08, 1996	Substantially Equivalent	Codonics, Inc.
K962967	FUJI MEDICAL DRY IMAGER FM-DP 2636	Oct 28, 1996	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K962051	ASPECT OPTICAM	Aug 23, 1996	Substantially Equivalent	Aspect Electronics, Inc.
K953165	ULTRA COMPACT VIDEO IMAGER	May 07, 1996	Substantially Equivalent	International Imaging Electronics
K955394	SIENET TELERADIOLOGY PRODUCT LINE	Feb 21, 1996	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K954149	ASPECT DIGITAL FORMATTER	Nov 13, 1995	Substantially Equivalent	Aspect Electronics, Inc.
K953477	MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING	Oct 07, 1995	Substantially Equivalent	The DU Pont Co.
K953475	CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING	Oct 07, 1995	Substantially Equivalent	The DU Pont Co.
K954198	VOXCAM	Sep 29, 1995	Substantially Equivalent	Voxel
K951948	KODAK XLS 8600 (PS)	Sep 13, 1995	Substantially Equivalent	Kodak Health Imaging Systems, Inc.
K951807	KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER	Sep 13, 1995	Substantially Equivalent	Kodak Health Imaging Systems, Inc.
K950359	KONICA LASER IMAGER LI-21	Sep 06, 1995	Substantially Equivalent	Storch Amini & Munves PC
K950721	FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L	May 24, 1995	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K950423	MINI IMAGER	May 12, 1995	Substantially Equivalent	Regulatory Management Services
K950610	FIKO FO;, TJER,A; O,AGER FTO-1000	Apr 25, 1995	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K950288	AUTOLASER MULTI FORMAT CAMERA	Apr 04, 1995	Substantially Equivalent	Afp Imaging Corp.
K945475	FUJI MEDICAL LASER IMAGER FL-IM D	Mar 09, 1995	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K936152	3M 1152 LASER IMAGER	Sep 21, 1994	Substantially Equivalent	3M Information,Imaging and Electronic Sector
K936142	3M 1154 LASER IMAGER	Sep 16, 1994	Substantially Equivalent	3M Information,Imaging and Electronic Sector
K940332	MODEL FORTY ULTRA COMPACT VIDEO IMAGER	Jun 08, 1994	Substantially Equivalent	International Imaging Electronics
K930755	ULTRA COMPACT VIDEO IMAGER	Sep 28, 1993	Substantially Equivalent	International Imaging Electronics
K925650	IMAGEVIEW 5000	Sep 14, 1993	Substantially Equivalent	Nuclear Data Systems
K925265	IMAGEVIEW 46000	Jun 09, 1993	Substantially Equivalent	Canberra Industries, Inc.
K925220	PMI100 VIDEO IMAGER	May 20, 1993	Substantially Equivalent	Heraeus Kulzer, Inc.
K923481	PHILIPS LASER DISK ARCHIVE	May 05, 1993	Substantially Equivalent	Philips Medical Systems, Inc.
K925289	MATRIX CR 2050, PMI 3000	Apr 08, 1993	Substantially Equivalent	Heraeus Kulzer, Inc.
K921215	LASERSTAR IMAGER	Feb 05, 1993	Substantially Equivalent	Frantz Imaging, Inc.
K923536	NUCLEAR MEDICINE LASER IMAGER	Nov 30, 1992	Substantially Equivalent	General Scanning, Inc.
K921906	HARRIS MODEL 2000	Nov 02, 1992	Substantially Equivalent	Harris Mfg. Co.
K921381	MEDGRAPHIX INTL VR 1000 SERIES	Nov 02, 1992	Substantially Equivalent	Medgraphix Intl.
K923222	3M COLOR LASER IMAGER, MODEL 979	Sep 30, 1992	Substantially Equivalent	3M Medical Products Group
K923075	3M LASER IMAGER MODEL 969	Sep 23, 1992	Substantially Equivalent	3M Medical Products Group
K922411	KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000	Aug 24, 1992	Substantially Equivalent	Eastman Kodak Company
K921992	MP3000 SERIES III VIDEO IMAGER	Jul 10, 1992	Substantially Equivalent	International Imaging Electronics
K921743	KODAK EKTASCAN 2180 LASER PRINTER	Jul 01, 1992	Substantially Equivalent	Eastman Kodak Company
K920769	KONICA LI 10 AND 10A LASER IMAGER	May 06, 1992	Substantially Equivalent	Konica Corp.
K914834	VORTECH 3M NETWORK PRINTING	Mar 06, 1992	Substantially Equivalent	Vortech Data, Inc.
K914582	KODAK EKTASCAN 1120 LASER PRINTER	Dec 19, 1991	Substantially Equivalent	Eastman Kodak Company
K912799	EAGLE SYSTEM	Dec 18, 1991	Substantially Equivalent	Marquette Electronics, Inc.
K912073	POLAROID HELIOS LASER IMAGER	Aug 28, 1991	Substantially Equivalent	Polaroid Medical Corp.
K911437	KODAK EKTASCAN CABLE EXTENSION	May 17, 1991	Substantially Equivalent	Eastman Kodak Company
K910092	3M LASER IMAGER XL	Apr 08, 1991	Substantially Equivalent	3M Medical Products Group
K902347	COMPACT LASER IMAGER, MODEL CLI-100	Mar 04, 1991	Substantially Equivalent	Lumisys, Inc.
K905566	KODAK EKTASCAN MULTI-FORMAT IMAGER VARIOUS MODELS	Jan 03, 1991	Substantially Equivalent	Eastman Kodak Company
K904897	MODEL 400 ULTRA COMPACT VIDEO IMAGER	Nov 20, 1990	Substantially Equivalent	International Imaging Electronics
K904363	MULTI FORMAT VIDEO IMAGER 600 PLUS	Nov 13, 1990	Substantially Equivalent	International Imaging Electronics
K903238	AFGA VIDEO IMAGER, VARIOUS MODELS	Nov 02, 1990	Substantially Equivalent	Enhanced Imaging Technologies, Inc.
K900901	MP4000 SERIES II COMPACT VIDEO IMAGER	Apr 30, 1990	Substantially Equivalent	International Imaging Electronics
K900900	MP3000 SERIES II COMPACT VIDEO IMAGER	Apr 30, 1990	Substantially Equivalent	International Imaging Electronics
K900899	MP3000 COMPACT VIDEO IMAGER	Apr 30, 1990	Substantially Equivalent	International Imaging Electronics
K900896	6000 PLUS MULTI-FORMAT VIDEO IMAGER	Apr 30, 1990	Substantially Equivalent	International Imaging Electronics
K900898	9000 ECONOMICAL 14 X 17 VIDEO IMAGER	Apr 19, 1990	Substantially Equivalent	International Imaging Electronics
K900897	5000/5000C MULTI-FORMAT CAMERAS FOR NUCLEAR MEDI.	Apr 19, 1990	Substantially Equivalent	International Imaging Electronics
K900885	FUJI MEDICAL LASER IMAGER	Mar 23, 1990	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K896683	COMPACT VIDEO IMAGER MP4000 SERIES III	Jan 22, 1990	Substantially Equivalent	International Imaging Electronics
K895668	DIGICAM LHP (VIDEO INTERFACE OPTION)	Nov 15, 1989	Substantially Equivalent	Siemens Gammasonics, Inc.
K891924	SCOPIX LASER IMAGER	May 18, 1989	Substantially Equivalent	Enhanced Imaging Technologies, Inc.
K883324	DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)	Feb 27, 1989	Substantially Equivalent	Siemens Gammasonics, Inc.
K890097	KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 1000	Feb 16, 1989	Substantially Equivalent	Eastman Kodak Company
K885127	SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM	Feb 16, 1989	Substantially Equivalent	Fischer Imaging Corp.
K882096	SCOPIX VIDEO IMAGER	Aug 09, 1988	Substantially Equivalent	Agfa-Gevaert, Inc.
K882483	FTI 200 MEDICAL THERMAL IMAGER	Aug 04, 1988	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K871959	FRANTZ IMAGING COMPACT CAMERA	Jun 22, 1987	Substantially Equivalent	Frantz Imaging, Inc.
K871958	SPACEMISER 8-17 FILM RECORDER	Jun 22, 1987	Substantially Equivalent	Frantz Imaging, Inc.
K871957	SPACEMISER 8-10 FILM RECORDER	Jun 22, 1987	Substantially Equivalent	Frantz Imaging, Inc.
K871778	DIGISPOT IMAGER	May 29, 1987	Substantially Equivalent	Siemens Gammasonics, Inc.
K863629	KODAK EKTASCAN LASER PRINTER, MODEL 100	Oct 27, 1986	Substantially Equivalent	Eastman Kodak Company
K863856	S-RAY CAMERA	Oct 14, 1986	Substantially Equivalent	Uni-Quatro Industries
K862416	FTI 100 MEDICAL THERMAL IMAGER	Jul 01, 1986	Substantially Equivalent	Parexel Intl. Corp.
K860776	MATRIX LR, LR 22A & LR/LASER RECORDER	Jun 16, 1986	Substantially Equivalent	Matrix Instruments
K860761	MULTI-IMAGE CAMERA, SERIES 2100, MODEL #2100-06	Apr 01, 1986	Substantially Equivalent	Lenzar Optics Corp.
K860691	KODAK EKTASCAN VIDEO CAMERA & COMPACT VIDEO CAMERA	Mar 13, 1986	Substantially Equivalent	Eastman Kodak Company
K855043	3M DRY SILVER IMAGER	Jan 10, 1986	Substantially Equivalent	3M Company
K850184	MEDICAL MULTI-IMAGE CAMERA-676	Feb 21, 1985	Substantially Equivalent	Dunn Instruments, Inc.
K843502	3M LASER IMAGER	Nov 29, 1984	Substantially Equivalent	3M Company
K843582	MULTI-FORMAT FILM CAMERA	Oct 25, 1984	Substantially Equivalent	Bfi- Medical Waste Systems
K840385	VIDEO PRINT	Feb 27, 1984	Substantially Equivalent	Advanced Instruments, Inc.