Product Code: LMA FDA class 2 21 CFR 892.2030

Digitizer, Image, Radiological

Radiology

Digitizer, Image, Radiological is a device that converts analog radiological images, such as those from conventional X-ray film, into digital format for storage, processing, transmission, or display within a digital imaging system. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LMA, regulated under 21 CFR 892.2030, within the Radiology medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: LMA
Device Class: FDA class 2
Regulation Number: 892.2030
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 61 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K132183	DICOM VIDEO	Oct 03, 2013	Substantially Equivalent	Bar Code Computer, Ltd.
K130636	TELERADPRO EDGE; TELERADPRO EDGE HD-CCD	Jun 07, 2013	Substantially Equivalent	Vidar Systems Corp.
K130406	DIAGNOSTICPRO EDGE	Apr 29, 2013	Substantially Equivalent	Vidar Systems Corp.
K102476	TELERADPRO	Oct 07, 2010	Substantially Equivalent	Vidar Systems Corp.
K093809	VIDAR DENTAL FILM DIGITIZER	Jan 07, 2010	Substantially Equivalent	Vidar Systems Corp.
K091288	MEDI-6000 MEDICAL IMAGE DIGITIZER	Aug 14, 2009	Substantially Equivalent	Microtek International, Inc.
K063424	FILM DIGITZER, MODEL 2908 MAMMO PRO	Dec 21, 2006	Substantially Equivalent	Array Corp.
K042484	NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER	Oct 20, 2004	Substantially Equivalent	Nai Technology Products
K033637	MEDICAL IMAGE DIGITIZER, MODEL 2908	Dec 17, 2003	Substantially Equivalent	Array Corp.
K032022	DIGITAL IMAGER	Sep 02, 2003	Substantially Equivalent	Pyramid Medical, Inc.
K022810	COBRASCAN CR-1 FILMLESS	Oct 11, 2002	Substantially Equivalent	Radiographic Digital Imaging, Inc.
K021949	FULCRUM	Aug 12, 2002	Substantially Equivalent	Howtek, Inc.
K020243	LASERPRO 16	Mar 05, 2002	Substantially Equivalent	Eradlink, Inc.
K013631	EFILM VIDEO	Nov 20, 2001	Substantially Equivalent	Efilm Medical, Inc.
K013395	LIFEJET VIDEO LINK	Oct 30, 2001	Substantially Equivalent	Ferrania S.P.A.
K011049	EXPRESSSUITE	Oct 01, 2001	Substantially Equivalent	Vidar Systems Corp.
K001841	35/CD CINECONVERTER	Nov 15, 2000	Substantially Equivalent	Tagarno A/S
K000411	CHILI VIDEO, CHILI VIDEOPRO	Apr 14, 2000	Substantially Equivalent	Steinbeis-Transferzentrum Medizinische Informatik
K992467	IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM	Feb 10, 2000	Substantially Equivalent	Dba Systems, Inc.
K993598	MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205	Jan 20, 2000	Substantially Equivalent	Vidar Systems Corp.
K993599	DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019	Jan 18, 2000	Substantially Equivalent	Vidar Systems Corp.
K993597	PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617	Dec 15, 1999	Substantially Equivalent	Vidar Systems Corp.
K990066	CCD CAMERA, MODEL 9000	Mar 17, 1999	Substantially Equivalent	Camtronics, Ltd.
K984409	ELK LASER FILM DIGITIZER	Feb 12, 1999	Substantially Equivalent	Nishimoto Sangyo Co., Ltd.
K984252	IMATION TRIMATIC DIGITAL SYSTEM	Jan 25, 1999	Substantially Equivalent	Imation Corp.
K982785	FILM DIGITIZER MODEL 2905	Oct 15, 1998	Substantially Equivalent	Array Corp.
K980873	KONICA DIRECT DIGITIZER REGIUS MODEL 330	Jun 19, 1998	Substantially Equivalent	Konica Corp.
K980809	LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER	May 11, 1998	Substantially Equivalent	Lumisys, Inc.
K974315	VIDAR VXR LS LASER FILM DIGITIZER	Apr 17, 1998	Substantially Equivalent	Vidar Systems Corp.
K980565	LD2000 SERIES	Mar 19, 1998	Substantially Equivalent	General Scanning, Inc.
K980213	DI-2000	Mar 17, 1998	Substantially Equivalent	Lumisys, Inc.
K974619	SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM	Feb 25, 1998	Substantially Equivalent	Afp Imaging Corp.
K973411	DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)	Dec 04, 1997	Substantially Equivalent	General Scanning, Inc.
K971894	KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM	Aug 20, 1997	Substantially Equivalent	Eastman Kodak Company
K970908	HOWTEK 960	May 20, 1997	Substantially Equivalent	Howtek, Inc.
K964288	CALL-RAD PC TELERADIOLOGY	Apr 23, 1997	Substantially Equivalent	Pc Teleradiology
K960839	FILM SCANNER 300	Dec 18, 1996	Substantially Equivalent	Cannon U.S.A., Inc.
K961768	KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)	Aug 22, 1996	Substantially Equivalent	Kodak Health Imaging Systems, Inc.
K953117	SCANMASTER DX	Jan 18, 1996	Substantially Equivalent	Howtek, Inc.
K954875	ASPECT ACQUISITION MODULE (AAM)	Jan 02, 1996	Substantially Equivalent	Aspect Electronics, Inc.
K953942	COBRASCAN CX-312	Dec 22, 1995	Substantially Equivalent	Radiographic Digital Imaging, Inc.
K952485	LASERNET IMAGE MANAGER/PRINT SERVER	Nov 24, 1995	Substantially Equivalent	Frantz Imaging, Inc.
K953964	LUMISYS, LUMISCAN 20	Sep 18, 1995	Substantially Equivalent	Lumisys, Inc.
K943357	CEMAX SCANLINK V	Nov 22, 1994	Substantially Equivalent	Cemax, Inc.
K932760	DFS-2100	Oct 20, 1994	Substantially Equivalent	Dba Systems, Inc.
K925799	AD/V A.5	Feb 18, 1994	Substantially Equivalent	Adaptive Video, Inc.
K933830	KONICA LD-4500 LASER DIGITIZER	Dec 14, 1993	Substantially Equivalent	Konica Medical Corp.
K933632	MEDSCAN 12	Dec 13, 1993	Substantially Equivalent	Vidar Systems Corp.
K933129	LUMISCAN 50	Oct 07, 1993	Substantially Equivalent	Lumisys, Inc.
K925721	KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE	Feb 26, 1993	Substantially Equivalent	Eastman Kodak Company
K924478	MTV-250A, MTV-300A	Dec 04, 1992	Substantially Equivalent	Toshiba America Medical Systems, In.C
K911082	REAL TIME X-RAY IMAGING SYSTEM	May 01, 1991	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K901423	DIGITAL IMAGE SCANNER, MODEL DIS-1000	Apr 30, 1990	Substantially Equivalent	Lumisys, Inc.
K896739	KONICA KFDR-S	Apr 30, 1990	Substantially Equivalent	Konica Medical Corp.
K896223	PHOTOPHONE	Feb 12, 1990	Substantially Equivalent	Image Data Corp.
K894412	RADIOSCOPE OR MAMMOSCOPE	Dec 22, 1989	Substantially Equivalent	Vision Ten, Inc.
K890970	TRUVEL TZ-3X X-RAY DIGITIZING SCANNER	May 11, 1989	Substantially Equivalent	Truvel Corp.
K890477	THE SPANTRON FRAME FREEZE	Mar 31, 1989	Substantially Equivalent	Spantron, Inc.
K874778	KODAK EKTASCAN IMAGE TRANSMISSION SYST T1/R1 SFTWR	Feb 23, 1989	Substantially Equivalent	Eastman Kodak Company
K860777	MATRIX LD & LD/LASER DIGITIZER	Apr 22, 1987	Substantially Equivalent	Matrix Instruments
K850330	ANGIOTEC SC 1221 SCAN CONVERTER	Apr 30, 1985	Substantially Equivalent	Angiotec