Product code LMA
- Device name
- Digitizer, Image, Radiological
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.2030
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132183 | DICOM VIDEO | Bar Code Computer, Ltd. | 2013-10-03 |
| K130636 | TELERADPRO EDGE; TELERADPRO EDGE HD-CCD | Vidar Systems Corp. | 2013-06-07 |
| K130406 | DIAGNOSTICPRO EDGE | Vidar Systems Corp. | 2013-04-29 |
| K102476 | TELERADPRO | Vidar Systems Corp. | 2010-10-07 |
| K093809 | VIDAR DENTAL FILM DIGITIZER | Vidar Systems Corp. | 2010-01-07 |
| K091288 | MEDI-6000 MEDICAL IMAGE DIGITIZER | Microtek International, Inc. | 2009-08-14 |
| K063424 | FILM DIGITZER, MODEL 2908 MAMMO PRO | Array Corp. | 2006-12-21 |
| K042484 | NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER | Nai Technology Products | 2004-10-20 |
| K033637 | MEDICAL IMAGE DIGITIZER, MODEL 2908 | Array Corp. | 2003-12-17 |
| K032022 | DIGITAL IMAGER | Pyramid Medical, Inc. | 2003-09-02 |
| K022810 | COBRASCAN CR-1 FILMLESS | Radiographic Digital Imaging, Inc. | 2002-10-11 |
| K021949 | FULCRUM | Howtek, Inc. | 2002-08-12 |
| K020243 | LASERPRO 16 | Eradlink, Inc. | 2002-03-05 |
| K013631 | EFILM VIDEO | Efilm Medical, Inc. | 2001-11-20 |
| K013395 | LIFEJET VIDEO LINK | Ferrania S.P.A. | 2001-10-30 |
| K011049 | EXPRESSSUITE | Vidar Systems Corp. | 2001-10-01 |
| K001841 | 35/CD CINECONVERTER | Tagarno A/S | 2000-11-15 |
| K000411 | CHILI VIDEO, CHILI VIDEOPRO | Steinbeis-Transferzentrum Medizinische Informatik | 2000-04-14 |
| K992467 | IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM | Dba Systems, Inc. | 2000-02-10 |
| K993598 | MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 | Vidar Systems Corp. | 2000-01-20 |
| K993599 | DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 | Vidar Systems Corp. | 2000-01-18 |
| K993597 | PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 | Vidar Systems Corp. | 1999-12-15 |
| K990066 | CCD CAMERA, MODEL 9000 | Camtronics, Ltd. | 1999-03-17 |
| K984409 | ELK LASER FILM DIGITIZER | Nishimoto Sangyo Co., Ltd. | 1999-02-12 |
| K984252 | IMATION TRIMATIC DIGITAL SYSTEM | Imation Corp. | 1999-01-25 |
| K982785 | FILM DIGITIZER MODEL 2905 | Array Corp. | 1998-10-15 |
| K980873 | KONICA DIRECT DIGITIZER REGIUS MODEL 330 | Konica Corp. | 1998-06-19 |
| K980809 | LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER | Lumisys, Inc. | 1998-05-11 |
| K974315 | VIDAR VXR LS LASER FILM DIGITIZER | Vidar Systems Corp. | 1998-04-17 |
| K980565 | LD2000 SERIES | General Scanning, Inc. | 1998-03-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04056481140502 | Patient Data Manager | Brainlab SE | 2018-06-15 |
| 04056481138615 | PATIENT DATA MANAGER 2.4 INSTALLER | Brainlab SE | 2018-02-09 |
| 04056481132453 | Origin Data Management / Patient Data Manager | Brainlab SE | 2017-01-02 |
| 00850677007082 | MDR Video Touch | HYLAND LLC | 2016-09-26 |
| 00851194002017 | Vidar Systems Corporation | VIDAR SYSTEMS CORPORATION | 2016-09-25 |
| 00851194002147 | Vidar Systems Corporation | VIDAR SYSTEMS CORPORATION | 2016-09-25 |
| 00851194002130 | Vidar Systems Corporation | VIDAR SYSTEMS CORPORATION | 2016-09-25 |
| 00851194002123 | Vidar Systems Corporation | VIDAR SYSTEMS CORPORATION | 2016-09-25 |
| 00851194002116 | Vidar Systems Corporation | VIDAR SYSTEMS CORPORATION | 2016-09-25 |
| 00851194002109 | Vidar Systems Corporation | VIDAR SYSTEMS CORPORATION | 2016-09-25 |
| 00851194002093 | Vidar Systems Corporation | VIDAR SYSTEMS CORPORATION | 2016-09-25 |
| 00851194002048 | Vidar Systems Corporation | VIDAR SYSTEMS CORPORATION | 2016-09-25 |
| 00851194002031 | Vidar Systems Corporation | VIDAR SYSTEMS CORPORATION | 2016-09-25 |
| 00851194002000 | Vidar Systems Corporation | VIDAR SYSTEMS CORPORATION | 2016-09-25 |
| 00866389000167 | Radlink Laser Pro 16 | RADLINK, INC. | 2016-09-21 |
| 00850677007075 | MDR Video Speech | HYLAND LLC | 2016-09-19 |
| 00850677007068 | MDR Video Cart | HYLAND LLC | 2016-09-19 |
| 00850677007037 | Dicom Box | HYLAND LLC | 2016-09-16 |
| 00850677007020 | MDR Video | HYLAND LLC | 2016-09-16 |
| 04056481006662 | Origin Data Management / Patient Data Manager | Brainlab SE | 2016-09-15 |