Camera, Multi Format, Radiological
FDA product code LMC · Class II (moderate risk) · 21 CFR 892.2040 · Radiology
121510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Eastman Kodak Company 14
- International Imaging Electronics 13
- Fujifilm Medical System U.S.A., Inc. 7
- Codonics, Inc. 6
- AGFA Corp. 6
- Frantz Imaging, Inc. 4
- Konica Minolta Medical & Graphic, Inc. 4
- Sony Electronics, Inc. 3
- Siemens Gammasonics, Inc. 3
- 3M Medical Products Group 3
- Kodak Health Imaging Systems, Inc. 2
- Aspect Electronics, Inc. 2
- The DU Pont Co. 2
- 3M Information,Imaging and Electronic Sector 2
- Enhanced Imaging Technologies, Inc. 2
- 3M Company 2
- Sterling Diagnostic Imaging, Inc. 2
- Seiko Instruments USA, Inc. 2
- Heraeus Kulzer, Inc. 2
- Konica Corp. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141454 | Sony Digital Printer UP-D898MD/SONY Hybrid Printer UP-X898MDLMC · Traditional | Sony Electronics, Inc. | 06/26/2014SE |
| K141346 | Sony Hybird Graphic UP-971AD, Sony Hybird Graphic Printer UP-991ADLMC · Traditional | Sony Electronics, Inc. | 06/26/2014SE |
| K111566 | Dryview Chroma Imaging SystemLMC · Traditional | Carestream Health, Inc. | 10/06/2011SE |
| K092280 | Cypher Dicom Print SolutionLMC · Traditional | Virtual Imaging, Inc. | 10/16/2009SE |
| K090469 | Carestream Dryview 5850 Laser ImagerLMC · Traditional | Carestream Health, Inc. | 05/22/2009SE |
| K083522 | Sony UP-DF750 Digital Film ImagerLMC · Traditional | Sony Electronics, Inc. | 01/09/2009SE |
| K081637 | Laser Imager Drypro Model 873LMC · Special | Konica Minolta Medical & Graphic, Inc. | 07/01/2008SE |
| K072680 | Drystar Axys, Model EYZ4ELMC · Special | Agfa Healthcare Corporation | 10/25/2007SE |
| K061999 | Dry Laser Imager, Drypro Model 832LMC · Traditional | Konica Minolta Medical & Graphic, Inc. | 08/15/2006SE |
| K061302 | Digital Printer P6000D Series, Model P6000DULMC · Traditional | Mitsubishi Electric Corporation Kyoto Works | 06/23/2006SE |
| K060440 | Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon Xl-X Long Film…LMC · Special | Codonics, Inc. | 03/16/2006SE |
| K052251 | Drystar Model 5500LMC · Traditional | Agfa Corporation | 08/31/2005SE |
| K042133 | Dry Laser Imager, Model Drypro Model 793LMC · Traditional | Konica Minolta Medical & Graphic, Inc. | 11/24/2004SE |
| K042232 | NP-2600 Series Hardcopy PrintersLMC · Traditional | Codonics, Inc. | 10/05/2004SE |
| K042159 | Kodak Color Medical Imager 1000LMC · Traditional | Eastman Kodak Company | 09/24/2004SE |
| K042158 | Kodak Medical Imager 300LMC · Traditional | Eastman Kodak Company | 09/24/2004SE |
| K033821 | Kodak Dryview 8900 Laser Imager Mammography AccessoryLMC · Traditional | Eastman Kodak Company | 02/20/2004SE |
| K033377 | Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and Fm-Dp LLMC · Traditional | Fujifilm Medical System U.S.A., Inc. | 01/09/2004SE |
| K032681 | Konica Laser Imager, Model Drypro Model 771LMC · Special | Konica Medical and Graphic Corporation | 09/24/2003SE |
| K032635 | Drystar 5300 Medical Image Printer, Model 5300LMC · Special | Agfa Corp. | 09/24/2003SE |
| K030690 | Codonics EP-1000 Medical Color Dry ImagersLMC · Traditional | Codonics, Inc. | 04/30/2003SE |
| K024188 | UP-DF500 Filmstation Digital Film ImagerLMC · Traditional | Sony Medical Systems | 02/04/2003SE |
| K023287 | Drystar 5500LMC · Special | Agfa Corp. | 10/22/2002SE |
| K022658 | LR Dicom ControllerLMC · Special | Agfa Corp. | 09/06/2002SE |
| K021054 | Codonics Horizon Ci Medical Multimedia Dry Imager; Codonics Horizon GS Medical…LMC · Traditional | Codonics, Inc. | 05/09/2002SE |
| K013052 | Konica Laser Imager, Drypro Model 751/752LMC · Traditional | Konica Minolta Medical & Graphic, Inc. | 01/16/2002SE |
| K012941 | Drystar, Model 4500MLMC · Traditional | Agfa Corp. | 11/29/2001SE |
| K012010 | Modification to LR 5200 Film RecorderLMC · Traditional | Agfa Corp. | 09/20/2001SE |
| K011949 | Elk Laser Imager, Model El-Dry 4000LMC · Traditional | Nishimoto Sangyo Co., Ltd. | 08/29/2001SE |
| K011617 | Lifejet Printer 400LMC · Traditional | Ferrania S.P.A. Stabilimento DI Ferrania | 06/08/2001SE |
| K010275 | Drystar 4500 Printer, Model 4500LMC · Traditional | Agfa Medical Imaging | 04/27/2001SE |
| K003481 | Codonics NP-1660 Series Medical Printers, Model 1660LMC · Traditional | Codonics, Inc. | 01/19/2001SE |
| K002146 | Kodak Dryview 8610 Laser Imager / for MammographyLMC · Traditional | Eastman Kodak Company | 09/27/2000SE |
| K992586 | Konica Laser Imager, Drypro Model 722LMC · Traditional | Konica Corp. | 10/29/1999SE |
| K991282 | Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 SeriesLMC · Traditional | Seiko Instruments USA, Inc. | 06/30/1999SE |
| K983905 | Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital Science 1200…LMC · Traditional | Eastman Kodak Company | 01/25/1999SE |
| K972822 | Imation SE-204 Laser ImagerLMC · Traditional | Imation Enterprises Corp. | 11/19/1997SE |
| K972660 | Raven Dry PrinterLMC · Traditional | Sterling Diagnostic Imaging, Inc. | 11/10/1997SE |
| K973422 | Lasershare Print SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS Nt])LMC · Traditional | Dejarnette Research Systems | 10/28/1997SE |
| K973028 | Helios Laser Imager 1417LMC · Traditional | Sterling Diagnostic Imaging, Inc. | 10/28/1997SE |
| K972847 | Kodak Digital Science 9000D Medical Laser Printer (9000D)LMC · Traditional | Eastman Kodak Company | 10/07/1997SE |
| K971760 | Colorpoint or Professional ColorpointLMC · Traditional | Seiko Instruments USA, Inc. | 10/01/1997SE |
| K972163 | Imation SE-196 Laser ImagerLMC · Traditional | Imation Corp. | 09/05/1997SE |
| K964414 | LR 5200 Laser Film RecorderLMC · Traditional | Bayer Corp., Agfa Div. | 01/27/1997SE |
| K962364 | Codonics Medical Printer (NP-1600M,NP1600MD)LMC · Traditional | Codonics, Inc. | 11/08/1996SE |
| K962967 | Fuji Medical Dry Imager Fm-Dp 2636LMC · Traditional | Fujifilm Medical System U.S.A., Inc. | 10/28/1996SE |
| K962051 | Aspect OpticamLMC · Traditional | Aspect Electronics, Inc. | 08/23/1996SE |
| K953165 | Ultra Compact Video ImagerLMC · Traditional | International Imaging Electronics | 05/07/1996SE |
| K955394 | Sienet Teleradiology Product LineLMC · Traditional | Siemens Medical Solutions USA, Inc. | 02/21/1996SE |
| K954149 | Aspect Digital FormatterLMC · Traditional | Aspect Electronics, Inc. | 11/13/1995SE |
| K953477 | Modular Daylight Cassette for Video ImagingLMC · Traditional | The DU Pont Co. | 10/07/1995SE |
| K953475 | CDS Compact Daylight Cassette for Video ImagingLMC · Traditional | The DU Pont Co. | 10/07/1995SE |
| K954198 | VoxcamLMC · Traditional | Voxel | 09/29/1995SE |
| K951948 | Kodak XLS 8600 (PS)LMC · Traditional | Kodak Health Imaging Systems, Inc. | 09/13/1995SE |
| K951807 | Kodak Ektascan Triad Laser Printer System, Photon Laser PrinterLMC · Traditional | Kodak Health Imaging Systems, Inc. | 09/13/1995SE |
| K950359 | Konica Laser Imager LI-21LMC · Traditional | Storch Amini & Munves PC | 09/06/1995SE |
| K950721 | Fuji Medical Laser Imagermulti-Formatters MF-300 and MF-300LLMC · Traditional | Fujifilm Medical System U.S.A., Inc. | 05/24/1995SE |
| K950423 | Mini ImagerLMC · Traditional | Regulatory Management Services | 05/12/1995SE |
| K950610 | Fiko Fo;, Tjer,A; O,Ager FTO-1000LMC · Traditional | Fujifilm Medical System U.S.A., Inc. | 04/25/1995SE |
| K950288 | Autolaser Multi Format CameraLMC · Traditional | Afp Imaging Corp. | 04/04/1995SE |
| K945475 | Fuji Medical Laser Imager Fl-Im DLMC · Traditional | Fujifilm Medical System U.S.A., Inc. | 03/09/1995SE |
| K936152 | 3M 1152 Laser ImagerLMC · Traditional | 3M Information,Imaging and Electronic Sector | 09/21/1994SE |
| K936142 | 3M 1154 Laser ImagerLMC · Traditional | 3M Information,Imaging and Electronic Sector | 09/16/1994SE |
| K940332 | Model Forty Ultra Compact Video ImagerLMC · Traditional | International Imaging Electronics | 06/08/1994SE |
| K930755 | Ultra Compact Video ImagerLMC · Traditional | International Imaging Electronics | 09/28/1993SE |
| K925650 | Imageview 5000LMC · Traditional | Nuclear Data Systems | 09/14/1993SE |
| K925265 | Imageview 46000LMC · Traditional | Canberra Industries, Inc. | 06/09/1993SE |
| K925220 | PMI100 Video ImagerLMC · Traditional | Heraeus Kulzer, Inc. | 05/20/1993SE |
| K923481 | Philips Laser Disk ArchiveLMC · Traditional | Philips Medical Systems, Inc. | 05/05/1993SE |
| K925289 | Matrix CR 2050, Pmi 3000LMC · Traditional | Heraeus Kulzer, Inc. | 04/08/1993SE |
| K921215 | Laserstar ImagerLMC · Traditional | Frantz Imaging, Inc. | 02/05/1993SE |
| K923536 | Nuclear Medicine Laser ImagerLMC · Traditional | General Scanning, Inc. | 11/30/1992SE |
| K921906 | Harris Model 2000LMC · Traditional | Harris Mfg. Co. | 11/02/1992SE |
| K921381 | Medgraphix Intl VR 1000 SeriesLMC · Traditional | Medgraphix Intl. | 11/02/1992SE |
| K923222 | 3M Color Laser Imager, Model 979LMC · Traditional | 3M Medical Products Group | 09/30/1992SE |
| K923075 | 3M Laser Imager Model 969LMC · Traditional | 3M Medical Products Group | 09/23/1992SE |
| K922411 | Kodak Ektascan, XLT7720, XLT7700, PCD 2000LMC · Traditional | Eastman Kodak Company | 08/24/1992SE |
| K921992 | MP3000 Series III Video ImagerLMC · Traditional | International Imaging Electronics | 07/10/1992SE |
| K921743 | Kodak Ektascan 2180 Laser PrinterLMC · Traditional | Eastman Kodak Company | 07/01/1992SE |
| K920769 | Konica Li 10 and 10A Laser ImagerLMC · Traditional | Konica Corp. | 05/06/1992SE |
| K914834 | Vortech 3M Network PrintingLMC · Traditional | Vortech Data, Inc. | 03/06/1992SE |
| K914582 | Kodak Ektascan 1120 Laser PrinterLMC · Traditional | Eastman Kodak Company | 12/19/1991SE |
| K912799 | Eagle SystemLMC · Traditional | Marquette Electronics, Inc. | 12/18/1991SE |
| K912073 | Polaroid Helios Laser ImagerLMC · Traditional | Polaroid Medical Corp. | 08/28/1991SE |
| K911437 | Kodak Ektascan Cable ExtensionLMC · Traditional | Eastman Kodak Company | 05/17/1991SE |
| K910092 | 3M Laser Imager XLLMC · Traditional | 3M Medical Products Group | 04/08/1991SE |
| K902347 | Compact Laser Imager, Model CLI-100LMC · Traditional | Lumisys, Inc. | 03/04/1991SE |
| K905566 | Kodak Ektascan Multi-Format Imager Various ModelsLMC · Traditional | Eastman Kodak Company | 01/03/1991SE |
| K904897 | Model 400 Ultra Compact Video ImagerLMC · Traditional | International Imaging Electronics | 11/20/1990SE |
| K904363 | Multi Format Video Imager 600 PlusLMC · Traditional | International Imaging Electronics | 11/13/1990SE |
| K903238 | Afga Video Imager, Various ModelsLMC · Traditional | Enhanced Imaging Technologies, Inc. | 11/02/1990SE |
| K900901 | MP4000 Series II Compact Video ImagerLMC · Traditional | International Imaging Electronics | 04/30/1990SE |
| K900900 | MP3000 Series II Compact Video ImagerLMC · Traditional | International Imaging Electronics | 04/30/1990SE |
| K900899 | MP3000 Compact Video ImagerLMC · Traditional | International Imaging Electronics | 04/30/1990SE |
| K900896 | 6000 Plus Multi-Format Video ImagerLMC · Traditional | International Imaging Electronics | 04/30/1990SE |
| K900898 | 9000 Economical 14 X 17 Video ImagerLMC · Traditional | International Imaging Electronics | 04/19/1990SE |
| K900897 | 5000/5000C Multi-Format Cameras for Nuclear Medi.LMC · Traditional | International Imaging Electronics | 04/19/1990SE |
| K900885 | Fuji Medical Laser ImagerLMC · Traditional | Fujifilm Medical System U.S.A., Inc. | 03/23/1990SE |
| K896683 | Compact Video Imager MP4000 Series IIILMC · Traditional | International Imaging Electronics | 01/22/1990SE |
| K895668 | Digicam LHP (Video Interface Option)LMC · Traditional | Siemens Gammasonics, Inc. | 11/15/1989SE |
| K891924 | Scopix Laser ImagerLMC · Traditional | Enhanced Imaging Technologies, Inc. | 05/18/1989SE |
| K883324 | Digicam LHP (Digital Laser High Performance)LMC · Traditional | Siemens Gammasonics, Inc. | 02/27/1989SE |
| K890097 | Kodak Ektascan Laser Printer Digital, Model 1000LMC · Traditional | Eastman Kodak Company | 02/16/1989SE |
| K885127 | Sis 2000 Mammographic X-Ray SystemLMC · Traditional | Fischer Imaging Corp. | 02/16/1989SE |
| K882096 | Scopix Video ImagerLMC · Traditional | Agfa-Gevaert, Inc. | 08/09/1988SE |
| K882483 | Fti 200 Medical Thermal ImagerLMC · Traditional | Fujifilm Medical System U.S.A., Inc. | 08/04/1988SE |
| K871959 | Frantz Imaging Compact CameraLMC · Traditional | Frantz Imaging, Inc. | 06/22/1987SE |
| K871958 | Spacemiser 8-17 Film RecorderLMC · Traditional | Frantz Imaging, Inc. | 06/22/1987SE |
| K871957 | Spacemiser 8-10 Film RecorderLMC · Traditional | Frantz Imaging, Inc. | 06/22/1987SE |
| K871778 | Digispot ImagerLMC · Traditional | Siemens Gammasonics, Inc. | 05/29/1987SE |
| K863629 | Kodak Ektascan Laser Printer, Model 100LMC · Traditional | Eastman Kodak Company | 10/27/1986SE |
| K863856 | S-Ray CameraLMC · Traditional | Uni-Quatro Industries | 10/14/1986SE |
| K862416 | Fti 100 Medical Thermal ImagerLMC · Traditional | Parexel Intl. Corp. | 07/01/1986SE |
| K860776 | Matrix LR, LR 22A & Lr/Laser RecorderLMC · Traditional | Matrix Instruments | 06/16/1986SE |
| K860761 | Multi-Image Camera, Series 2100, Model #2100-06LMC · Traditional | Lenzar Optics Corp. | 04/01/1986SE |
| K860691 | Kodak Ektascan Video Camera & Compact Video CameraLMC · Traditional | Eastman Kodak Company | 03/13/1986SE |
| K855043 | 3M Dry Silver ImagerLMC · Traditional | 3M Company | 01/10/1986SE |
| K850184 | Medical Multi-Image CAMERA-676LMC · Traditional | Dunn Instruments, Inc. | 02/21/1985SE |
| K843502 | 3M Laser ImagerLMC · Traditional | 3M Company | 11/29/1984SE |
| K843582 | Multi-Format Film CameraLMC · Traditional | Bfi- Medical Waste Systems | 10/25/1984SE |
| K840385 | Video PrintLMC · Traditional | Advanced Instruments, Inc. | 02/27/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1607-2015 Class II | Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60)…The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet… | Philips Medical Systems (Cleveland) Inc | 03/11/2015Terminated |
| Z-2136-2008 | Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic…The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON". | AGFA Corp. | 05/16/2008Terminated |