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.
Recent Cleared Devices (20 of 61)
Showing 20 most recent of 61 cleared devices.
| 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 |
Top Applicants
- Vidar Systems Corp. — 10 clearances
- Lumisys, Inc. — 5 clearances
- Array Corp. — 3 clearances
- Eastman Kodak Company — 3 clearances
- Howtek, Inc. — 3 clearances
