FDA Product Code
FDA Product Code LMA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2030
510(k) Clearances — 61 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K132183 | DICOM VIDEO | Bar Code Computer, Ltd. | 2013-10-03 | Traditional | PDF ↗ |
| K130636 | TELERADPRO EDGE; TELERADPRO EDGE HD-CCD | Vidar Systems Corp. | 2013-06-07 | Traditional | PDF ↗ |
| K130406 | DIAGNOSTICPRO EDGE | Vidar Systems Corp. | 2013-04-29 | Traditional | PDF ↗ |
| K102476 | TELERADPRO | Vidar Systems Corp. | 2010-10-07 | Special | PDF ↗ |
| K093809 | VIDAR DENTAL FILM DIGITIZER | Vidar Systems Corp. | 2010-01-07 | Traditional | PDF ↗ |
| K091288 | MEDI-6000 MEDICAL IMAGE DIGITIZER | Microtek International, Inc. | 2009-08-14 | Traditional | PDF ↗ |
| K063424 | FILM DIGITZER, MODEL 2908 MAMMO PRO | Array Corp. | 2006-12-21 | Traditional | PDF ↗ |
| K042484 | NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER | Nai Technology Products | 2004-10-20 | Traditional | PDF ↗ |
| K033637 | MEDICAL IMAGE DIGITIZER, MODEL 2908 | Array Corp. | 2003-12-17 | Special | PDF ↗ |
| K032022 | DIGITAL IMAGER | Pyramid Medical, Inc. | 2003-09-02 | Traditional | PDF ↗ |
| K022810 | COBRASCAN CR-1 FILMLESS | Radiographic Digital Imaging, Inc. | 2002-10-11 | Traditional | PDF ↗ |
| K021949 | FULCRUM | Howtek, Inc. | 2002-08-12 | Traditional | PDF ↗ |
| K020243 | LASERPRO 16 | Eradlink, Inc. | 2002-03-05 | Traditional | PDF ↗ |
| K013631 | EFILM VIDEO | Efilm Medical, Inc. | 2001-11-20 | Traditional | PDF ↗ |
| K013395 | LIFEJET VIDEO LINK | Ferrania S.P.A. | 2001-10-30 | Traditional | PDF ↗ |
| K011049 | EXPRESSSUITE | Vidar Systems Corp. | 2001-10-01 | Traditional | PDF ↗ |
| K001841 | 35/CD CINECONVERTER | Tagarno A/S | 2000-11-15 | Traditional | PDF ↗ |
| K000411 | CHILI VIDEO, CHILI VIDEOPRO | Steinbeis-Transferzentrum Medizinische Informatik | 2000-04-14 | Abbreviated | PDF ↗ |
| K992467 | IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM | Dba Systems, Inc. | 2000-02-10 | Traditional | PDF ↗ |
| K993598 | MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 | Vidar Systems Corp. | 2000-01-20 | Traditional | PDF ↗ |
| K993599 | DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 | Vidar Systems Corp. | 2000-01-18 | Traditional | PDF ↗ |
| K993597 | PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 | Vidar Systems Corp. | 1999-12-15 | Traditional | PDF ↗ |
| K990066 | CCD CAMERA, MODEL 9000 | Camtronics, Ltd. | 1999-03-17 | Traditional | PDF ↗ |
| K984409 | ELK LASER FILM DIGITIZER | Nishimoto Sangyo Co., Ltd. | 1999-02-12 | Traditional | PDF ↗ |
| K984252 | IMATION TRIMATIC DIGITAL SYSTEM | Imation Corp. | 1999-01-25 | Traditional | PDF ↗ |
| K982785 | FILM DIGITIZER MODEL 2905 | Array Corp. | 1998-10-15 | Traditional | PDF ↗ |
| K980873 | KONICA DIRECT DIGITIZER REGIUS MODEL 330 | Konica Corp. | 1998-06-19 | Traditional | PDF ↗ |
| K980809 | LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER | Lumisys, Inc. | 1998-05-11 | Traditional | PDF ↗ |
| K974315 | VIDAR VXR LS LASER FILM DIGITIZER | Vidar Systems Corp. | 1998-04-17 | Traditional | PDF ↗ |
| K980565 | LD2000 SERIES | General Scanning, Inc. | 1998-03-19 | Traditional | PDF ↗ |
| K980213 | DI-2000 | Lumisys, Inc. | 1998-03-17 | Traditional | PDF ↗ |
| K974619 | SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM | Afp Imaging Corp. | 1998-02-25 | Traditional | PDF ↗ |
| K973411 | DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) | General Scanning, Inc. | 1997-12-04 | Traditional | PDF ↗ |
| K971894 | KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM | Eastman Kodak Company | 1997-08-20 | Traditional | PDF ↗ |
| K970908 | HOWTEK 960 | Howtek, Inc. | 1997-05-20 | Traditional | PDF ↗ |
| K964288 | CALL-RAD PC TELERADIOLOGY | Pc Teleradiology | 1997-04-23 | Traditional | PDF ↗ |
| K960839 | FILM SCANNER 300 | Cannon U.S.A., Inc. | 1996-12-18 | Traditional | PDF ↗ |
| K961768 | KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER) | Kodak Health Imaging Systems, Inc. | 1996-08-22 | Traditional | PDF ↗ |
| K953117 | SCANMASTER DX | Howtek, Inc. | 1996-01-18 | Traditional | PDF ↗ |
| K954875 | ASPECT ACQUISITION MODULE (AAM) | Aspect Electronics, Inc. | 1996-01-02 | Traditional | PDF ↗ |
| K953942 | COBRASCAN CX-312 | Radiographic Digital Imaging, Inc. | 1995-12-22 | Traditional | PDF ↗ |
| K952485 | LASERNET IMAGE MANAGER/PRINT SERVER | Frantz Imaging, Inc. | 1995-11-24 | Traditional | PDF ↗ |
| K953964 | LUMISYS, LUMISCAN 20 | Lumisys, Inc. | 1995-09-18 | Traditional | PDF ↗ |
| K943357 | CEMAX SCANLINK V | Cemax, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K932760 | DFS-2100 | Dba Systems, Inc. | 1994-10-20 | Traditional | PDF ↗ |
| K925799 | AD/V A.5 | Adaptive Video, Inc. | 1994-02-18 | Traditional | PDF ↗ |
| K933830 | KONICA LD-4500 LASER DIGITIZER | Konica Medical Corp. | 1993-12-14 | Traditional | PDF ↗ |
| K933632 | MEDSCAN 12 | Vidar Systems Corp. | 1993-12-13 | Traditional | PDF ↗ |
| K933129 | LUMISCAN 50 | Lumisys, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K925721 | KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE | Eastman Kodak Company | 1993-02-26 | Traditional | PDF ↗ |
| K924478 | MTV-250A, MTV-300A | Toshiba America Medical Systems, In.C | 1992-12-04 | Traditional | PDF ↗ |
| K911082 | REAL TIME X-RAY IMAGING SYSTEM | Siemens Medical Solutions USA, Inc. | 1991-05-01 | Traditional | PDF ↗ |
| K901423 | DIGITAL IMAGE SCANNER, MODEL DIS-1000 | Lumisys, Inc. | 1990-04-30 | Traditional | PDF ↗ |
| K896739 | KONICA KFDR-S | Konica Medical Corp. | 1990-04-30 | Traditional | PDF ↗ |
| K896223 | PHOTOPHONE | Image Data Corp. | 1990-02-12 | Traditional | PDF ↗ |
| K894412 | RADIOSCOPE OR MAMMOSCOPE | Vision Ten, Inc. | 1989-12-22 | Traditional | PDF ↗ |
| K890970 | TRUVEL TZ-3X X-RAY DIGITIZING SCANNER | Truvel Corp. | 1989-05-11 | Traditional | PDF ↗ |
| K890477 | THE SPANTRON FRAME FREEZE | Spantron, Inc. | 1989-03-31 | Traditional | PDF ↗ |
| K874778 | KODAK EKTASCAN IMAGE TRANSMISSION SYST T1/R1 SFTWR | Eastman Kodak Company | 1989-02-23 | Traditional | PDF ↗ |
| K860777 | MATRIX LD & LD/LASER DIGITIZER | Matrix Instruments | 1987-04-22 | Traditional | PDF ↗ |
| K850330 | ANGIOTEC SC 1221 SCAN CONVERTER | Angiotec | 1985-04-30 | Traditional | PDF ↗ |
Product code LMA · Class II · Radiology. Data: openFDA.