LMC · Camera, Multi Format, Radiological
Radiology · 21 CFR 892.2040 · Class 2
Overview
| Product Code | LMC |
|---|---|
| Device Name | Camera, Multi Format, Radiological |
| Regulation | 21 CFR 892.2040 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.
Classification Rationale
Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). 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., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). 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 121)
Showing 20 most recent of 121 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K141454 | SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD | Sony Electronics, Inc. | Jun 26, 2014 | SESE |
| K141346 | SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD | Sony Electronics, Inc. | Jun 26, 2014 | SESE |
| K111566 | DRYVIEW CHROMA IMAGING SYSTEM | Carestream Health, Inc. | Oct 6, 2011 | SESE |
| K092280 | CYPHER DICOM PRINT SOLUTION | Virtual Imaging, Inc. | Oct 16, 2009 | SESE |
| K090469 | CARESTREAM DRYVIEW 5850 LASER IMAGER | Carestream Health, Inc. | May 22, 2009 | SESE |
| K083522 | SONY UP-DF750 DIGITAL FILM IMAGER | Sony Electronics, Inc. | Jan 9, 2009 | SESE |
| K081637 | LASER IMAGER DRYPRO MODEL 873 | Konica Minolta Medical & Graphic, Inc. | Jul 1, 2008 | SESE |
| K072680 | DRYSTAR AXYS, MODEL EYZ4E | Agfa Healthcare Corporation | Oct 25, 2007 | SESE |
| K061999 | DRY LASER IMAGER, DRYPRO MODEL 832 | Konica Minolta Medical & Graphic, Inc. | Aug 15, 2006 | SESE |
| K061302 | DIGITAL PRINTER P6000D SERIES, MODEL P6000DU | Mitsubishi Electric Corporation Kyoto Works | Jun 23, 2006 | SESE |
| K060440 | CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER | Codonics, Inc. | Mar 16, 2006 | SESE |
| K052251 | DRYSTAR MODEL 5500 | Agfa Corporation | Aug 31, 2005 | SESE |
| K042133 | DRY LASER IMAGER, MODEL DRYPRO MODEL 793 | Konica Minolta Medical & Graphic, Inc. | Nov 24, 2004 | SESE |
| K042232 | NP-2600 SERIES HARDCOPY PRINTERS | Codonics, Inc. | Oct 5, 2004 | SESE |
| K042159 | KODAK COLOR MEDICAL IMAGER 1000 | Eastman Kodak Company | Sep 24, 2004 | SESE |
| K042158 | KODAK MEDICAL IMAGER 300 | Eastman Kodak Company | Sep 24, 2004 | SESE |
| K033821 | KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY | Eastman Kodak Company | Feb 20, 2004 | SESE |
| K033377 | FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L | Fujifilm Medical System U.S.A., Inc. | Jan 9, 2004 | SESE |
| K032681 | KONICA LASER IMAGER, MODEL DRYPRO MODEL 771 | Konica Medical and Graphic Corporation | Sep 24, 2003 | SESE |
| K032635 | DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 | Agfa Corp. | Sep 24, 2003 | SESE |
Top Applicants
- Eastman Kodak Company — 14 clearances
- International Imaging Electronics — 13 clearances
- Fujifilm Medical System U.S.A., Inc. — 7 clearances
- Codonics, Inc. — 6 clearances
- Agfa Corp. — 5 clearances
