LMA · Digitizer, Image, Radiological
Radiology · 21 CFR 892.2030 · Class 2
Overview
| Product Code | LMA |
|---|---|
| Device Name | Digitizer, Image, Radiological |
| Regulation | 21 CFR 892.2030 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.
Classification Rationale
Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Cleared Devices (61)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132183 | DICOM VIDEO | Bar Code Computer, Ltd. | Oct 3, 2013 | SESE |
| K130636 | TELERADPRO EDGE; TELERADPRO EDGE HD-CCD | Vidar Systems Corp. | Jun 7, 2013 | SESE |
| K130406 | DIAGNOSTICPRO EDGE | Vidar Systems Corp. | Apr 29, 2013 | SESE |
| K102476 | TELERADPRO | Vidar Systems Corp. | Oct 7, 2010 | SESE |
| K093809 | VIDAR DENTAL FILM DIGITIZER | Vidar Systems Corp. | Jan 7, 2010 | SESE |
| K091288 | MEDI-6000 MEDICAL IMAGE DIGITIZER | Microtek International, Inc. | Aug 14, 2009 | SESE |
| K063424 | FILM DIGITZER, MODEL 2908 MAMMO PRO | Array Corp. | Dec 21, 2006 | SESE |
| K042484 | NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER | Nai Technology Products | Oct 20, 2004 | SESE |
| K033637 | MEDICAL IMAGE DIGITIZER, MODEL 2908 | Array Corp. | Dec 17, 2003 | SESE |
| K032022 | DIGITAL IMAGER | Pyramid Medical, Inc. | Sep 2, 2003 | SESE |
| K022810 | COBRASCAN CR-1 FILMLESS | Radiographic Digital Imaging, Inc. | Oct 11, 2002 | SESE |
| K021949 | FULCRUM | Howtek, Inc. | Aug 12, 2002 | SESE |
| K020243 | LASERPRO 16 | Eradlink, Inc. | Mar 5, 2002 | SESE |
| K013631 | EFILM VIDEO | Efilm Medical, Inc. | Nov 20, 2001 | SESE |
| K013395 | LIFEJET VIDEO LINK | Ferrania S.P.A. | Oct 30, 2001 | SESE |
| K011049 | EXPRESSSUITE | Vidar Systems Corp. | Oct 1, 2001 | SESE |
| K001841 | 35/CD CINECONVERTER | Tagarno A/S | Nov 15, 2000 | SESE |
| K000411 | CHILI VIDEO, CHILI VIDEOPRO | Steinbeis-Transferzentrum Medizinische Informatik | Apr 14, 2000 | SESE |
| K992467 | IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM | Dba Systems, Inc. | Feb 10, 2000 | SESE |
| K993598 | MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 | Vidar Systems Corp. | Jan 20, 2000 | SESE |
| K993599 | DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 | Vidar Systems Corp. | Jan 18, 2000 | SESE |
| K993597 | PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 | Vidar Systems Corp. | Dec 15, 1999 | SESE |
| K990066 | CCD CAMERA, MODEL 9000 | Camtronics, Ltd. | Mar 17, 1999 | SESE |
| K984409 | ELK LASER FILM DIGITIZER | Nishimoto Sangyo Co., Ltd. | Feb 12, 1999 | SESE |
| K984252 | IMATION TRIMATIC DIGITAL SYSTEM | Imation Corp. | Jan 25, 1999 | SESE |
| K982785 | FILM DIGITIZER MODEL 2905 | Array Corp. | Oct 15, 1998 | SESE |
| K980873 | KONICA DIRECT DIGITIZER REGIUS MODEL 330 | Konica Corp. | Jun 19, 1998 | SESE |
| K980809 | LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER | Lumisys, Inc. | May 11, 1998 | SESE |
| K974315 | VIDAR VXR LS LASER FILM DIGITIZER | Vidar Systems Corp. | Apr 17, 1998 | SESE |
| K980565 | LD2000 SERIES | General Scanning, Inc. | Mar 19, 1998 | SESE |
| K980213 | DI-2000 | Lumisys, Inc. | Mar 17, 1998 | SESE |
| K974619 | SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM | Afp Imaging Corp. | Feb 25, 1998 | SESE |
| K973411 | DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) | General Scanning, Inc. | Dec 4, 1997 | SESE |
| K971894 | KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM | Eastman Kodak Company | Aug 20, 1997 | SESE |
| K970908 | HOWTEK 960 | Howtek, Inc. | May 20, 1997 | SESE |
| K964288 | CALL-RAD PC TELERADIOLOGY | Pc Teleradiology | Apr 23, 1997 | SESE |
| K960839 | FILM SCANNER 300 | Cannon U.S.A., Inc. | Dec 18, 1996 | SESE |
| K961768 | KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER) | Kodak Health Imaging Systems, Inc. | Aug 22, 1996 | SESE |
| K953117 | SCANMASTER DX | Howtek, Inc. | Jan 18, 1996 | SESE |
| K954875 | ASPECT ACQUISITION MODULE (AAM) | Aspect Electronics, Inc. | Jan 2, 1996 | SESE |
| K953942 | COBRASCAN CX-312 | Radiographic Digital Imaging, Inc. | Dec 22, 1995 | SESE |
| K952485 | LASERNET IMAGE MANAGER/PRINT SERVER | Frantz Imaging, Inc. | Nov 24, 1995 | SESE |
| K953964 | LUMISYS, LUMISCAN 20 | Lumisys, Inc. | Sep 18, 1995 | SESE |
| K943357 | CEMAX SCANLINK V | Cemax, Inc. | Nov 22, 1994 | SESE |
| K932760 | DFS-2100 | Dba Systems, Inc. | Oct 20, 1994 | SESE |
| K925799 | AD/V A.5 | Adaptive Video, Inc. | Feb 18, 1994 | SESE |
| K933830 | KONICA LD-4500 LASER DIGITIZER | Konica Medical Corp. | Dec 14, 1993 | SESE |
| K933632 | MEDSCAN 12 | Vidar Systems Corp. | Dec 13, 1993 | SESE |
| K933129 | LUMISCAN 50 | Lumisys, Inc. | Oct 7, 1993 | SESE |
| K925721 | KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE | Eastman Kodak Company | Feb 26, 1993 | SESE |
| K924478 | MTV-250A, MTV-300A | Toshiba America Medical Systems, In.C | Dec 4, 1992 | SESE |
| K911082 | REAL TIME X-RAY IMAGING SYSTEM | Siemens Medical Solutions USA, Inc. | May 1, 1991 | SESE |
| K901423 | DIGITAL IMAGE SCANNER, MODEL DIS-1000 | Lumisys, Inc. | Apr 30, 1990 | SESE |
| K896739 | KONICA KFDR-S | Konica Medical Corp. | Apr 30, 1990 | SESE |
| K896223 | PHOTOPHONE | Image Data Corp. | Feb 12, 1990 | SESE |
| K894412 | RADIOSCOPE OR MAMMOSCOPE | Vision Ten, Inc. | Dec 22, 1989 | SESE |
| K890970 | TRUVEL TZ-3X X-RAY DIGITIZING SCANNER | Truvel Corp. | May 11, 1989 | SESE |
| K890477 | THE SPANTRON FRAME FREEZE | Spantron, Inc. | Mar 31, 1989 | SESE |
| K874778 | KODAK EKTASCAN IMAGE TRANSMISSION SYST T1/R1 SFTWR | Eastman Kodak Company | Feb 23, 1989 | SESE |
| K860777 | MATRIX LD & LD/LASER DIGITIZER | Matrix Instruments | Apr 22, 1987 | SESE |
| K850330 | ANGIOTEC SC 1221 SCAN CONVERTER | Angiotec | Apr 30, 1985 | SESE |
Top Applicants
- Vidar Systems Corp. — 10 clearances
- Lumisys, Inc. — 5 clearances
- Howtek, Inc. — 3 clearances
- Eastman Kodak Company — 3 clearances
- Array Corp. — 3 clearances
