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510(k) Data Aggregation
K Number
K141346Device Name
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD
Manufacturer
SONY ELECTRONICS, INC.
Date Cleared
2014-06-26
(35 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sony Hybrid Graphic Printers UT-971AD and UP-991AD are compact, medical grode hlack and white printers that can accept both anslog and digital signal inpus. They are designed to be integrated into radiology imaging systems such as mobile c-arm, ultrasound, cardine intintion laboratory and other compaible medical imaging systems and produce hard copy prints of still images captured by these systems for the patient rocord or for referrals.
Device Description
The UP-991AD and UP-971AD Hybrid Graphic Printers are compact black and white printers designed for use with both analog and digital radiology imaging systems such as mobile C-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems. They provide 325 dpi high resolution hard copies of still images captured by the imaging system that can then be used as reference prints for patient record purposes or referrals.
Both the UP-991AD and UP-971AD Hybrid Graphic Printers provide a multi-picture print mode and panoramic print capability. Additionally, the UP-991AD can store images on a connected USB flash drive and print on transparent blue film media, in addition to paper media. Other conveniences offered by the UP-991AD include automatic detection of media type and an integrated media cutter.
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K Number
K141454Device Name
SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
Manufacturer
SONY ELECTRONICS, INC.
Date Cleared
2014-06-26
(24 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers are compact, medical grade black and white digital printers. The Sony UP-D898MD (Digital) Graphic Printer accepts only digital signal inputs. The Sony UP-X898MD (Hybrid) Graphic Printer can accept both analog and digital signal inputs. Both models are designed to be integrated into digital radiology imaging systems such as mobile c-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems and produce hard copy prints of still images captured by these systems for the patient record or for referrals.
Device Description
The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Printers are compact, medical grade black and white printers. The UP-D898MD only accepts digital signal inputs and the UP-X898MD accepts both analog and digital signal inputs. The printers are designed to be integrated into radiology imaging systems such as mobile c-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems and produce 325 dpi high resolution hard copy prints of still images captured by these systems for the patient record purposes or referrals. The images cannot be utilized for diagnostic purposes. Additionally, the UP-X898MD (Hybrid) Printer can store images on a connected USB flash drive.
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K Number
K111566Device Name
DRYVIEW CHROMA IMAGING SYSTEM
Manufacturer
CARESTREAM HEALTH,INC.
Date Cleared
2011-10-06
(122 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DRYVIEW CHROMA Imaging System is intended to provide hard copy images from digital imaging source output signals. The device is intended for use with DRYVIEW CHROMA film and reflective media. The device will interface with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging). The images are to be used for medical diagnosis and referral to physicians and their patients. The DRYVIEW CHROMA Imaging System is not intended for use with FFDM or CR Mammography systems.
Device Description
The DRYVIEW CHROMA Imaging System is an inkjet printing system. The DRYVIEW CHROMA Imaging System (CHROMA System) receives medical data including image and clinical report data from a digital modality. This data is received from medical image source devices (modalities) over a network and communicated to the CHROMA device via digital communication standard, DICOM. User control is performed directly by the modality or through the host control. The CHROMA System device prints the information received using piezoelectric inkjet technology. Tiny ink droplets are propelled from pizeoelectric nozzles in inige toenhology. " in media to form the image or report communicated by the digital modality. The CHROMA System device prints on transparent polyester based (film) as well as reflective (paper) media. Media is removed from a cartridge and transported into the CHROMA System device. Print data and media merge within the device. The CHROMA System employs the use of test patterns to verify imaging performance. A test pattern generator is incorporated to assure consistency between input signals and output density. Software is used to control the image management and machine functions. The information sent to the DICOM interface is used by the DICOM Interface to choose the correct set of printing parameters and halftone patterns for optimal image quality.
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K Number
K092280Device Name
CYPHER DICOM PRINT SOLUTION
Manufacturer
VIRTUAL IMAGING, INC.
Date Cleared
2009-10-16
(80 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for high resolution hard copy imaging of digital image source material (DICOM). The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning; Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians. Not for mammography use.
Device Description
CYPHER implements the necessary DICOM services to receive DICOM print jobs and provides an interface for printing the received data on a Windows™ printer. The device is designed for use with the CANON imagePRESS™ C1 Digital Print System. It consists of an Intel® 945GSE Mini-ITX Board in a shielded enclosure. The user interface is implemented on either an attached monitor or via the remote desktop function inherent in Windows XP. Power is supplied via an external UL listed 12 volt power supply.
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K Number
K090469Device Name
CARESTREAM DRYVIEW 5850 LASER IMAGER
Manufacturer
CARESTREAM HEALTH, INC.
Date Cleared
2009-05-22
(88 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide highresolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW media including DVM (DryView mammography) films. The imager with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging) and FFDM (Full Field Digital mammography). Image resizing is used to preserve true geometric size images. The images are to be used for medical diagnosis and referral to physicians and their patients.
Device Description
The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide highresolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW media including DVM (DryView mammography) films. The imager will interface with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging) and FFDM (Full Field Digital mammography). Image resizing is used to preserve true geometric size images. The images are to be used for medical diagnosis and referral to physicians and their patients.
The subject device and predicate devices use the same technical design base. The printers receive image data from the modality. User control is performed directly by the modality or through the host control. KODAK DRYVIEW imaging media is removed from a daylight cartridge and transported to the laser imaging station. Image data and media merge at the laser station and the film is scanned. The exposed media is transported through the integrated processor and exits the printer.
Software is used to control the image management and machine functions. AIQC (Automated Image Quality Control) matches printing power with film characteristics to provide consistently high image quality.
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K Number
K083522Device Name
SONY UP-DF750 DIGITAL FILM IMAGER
Manufacturer
SONY ELECTRONICS, INC.
Date Cleared
2009-01-09
(44 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sony UP-DF750 Digital Film Imager is a thermal printer intended for use in printing medical diagnostic images from mammography systems. The UP-DF750 is a multi-format imager and also is intended for printing high-resolution diagnostic images from CT, MRI, CR, DR and other compatible medical imaging systems. The Sony UP-DF750 is intended for use by medical radiologists or other appropriately trained medical personnel.
Device Description
The Sony UP-DF750 Digital Film Imager is a device for digitally printing black and white still images with DICOM format. The Sony UP-DF750 Digital Film Imager is connected to a DICOM network and the image from a mammography, CT, MRI, CR, DR or other compatible medical imaging system (modality) is transmitted via the DICOM network. Whenever a DICOM file is received, the Sony UP-DF750 Digital Film Imager will understand the DICOM information and images will be formatted in the memory. Then, this information will be transferred to the Print Engine through an internal interface (VF). The data will be processed through sharpness, gamma curve and other types of compensation. The Sony UP-DF750 Digital Film Imager is intended to be used to print DICOM images obtained from a medical modality for the purpose of diagnosis.
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K Number
K081637Device Name
LASER IMAGER DRYPRO MODEL 873
Manufacturer
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
Date Cleared
2008-07-01
(20 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LASER IMAGER, DRYPRO MODEL 873 is intended to be used to acquire images from diagnostic equipment such as CT, MRI, DSA or FDA-approved Full Field Digital Mammography System and print the images on medical dry-film. The devices are intended to be used by trained medical personnel in a clinic or hospital environment.
Device Description
The LASER IMAGER, DRYPRO MODEL 873 is a Medical Image Hardcopy Device to acquire images from diagnostic equipment such as CT, MRI, DSA or Full Field Digital Mammography System and print them on medical dry-film. The device consists of film supplying unit, film transferring unit, heat-developing unit, operating unit, power supplying unit and main control unit. This product employs semiconductor laser scanning and it complies with the Federal Performance Standard 21 CFR Part 1040.10.
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K Number
K072680Device Name
DRYSTAR AXYS, MODEL EYZ4E
Manufacturer
AGFA HEALTHCARE CORPORATION
Date Cleared
2007-10-25
(31 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Drystar AXYS is a free-standing dry film printer used to print diagnostic images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable, including digital mammography.
The Drystar AXYS is a free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
Device Description
The device is the new Drystar AXYS and it is a dry, B/W printer, using the direct thermal printing principle to produce continuous-tone images with medical diagnostic image quality onto plastic sheets which can be viewed on a light box. The printer is sold with two film input trays. Each tray can be adjusted to five different sizes (in inches) of film, including 8x10, 10x12, 11x14, 14x14 and 14x17. Three different types of film can be used in this new device, two for general purpose radiography and a new type of film for mammography, Drystar DT 2 M. The new mammography film comes in only two sizes 8x10 and 10x12. It is thicker than the general purpose radiography film in order to provide a wider range of optical densities. The printer also handles borders for mammography images in a different manner than for regular medical images.
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K Number
K061999Device Name
DRY LASER IMAGER, DRYPRO MODEL 832
Manufacturer
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
Date Cleared
2006-08-15
(32 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dry Laser Imager, DRYPRO Model 832 is intended to be used to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film. The output image is not a high resolution and DRYPRO Model 832 is not intended for use with FFDM systems.
Device Description
The Dry Laser Imager, DRYPRO Model 832 is a Laser Imager to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film. The device consists of film supplying unit, film transferring unit, exposing unit, heat-developing unit, operating unit, power supplying unit and main control unit. This product employs semiconductor laser scanning, but it complies with the Federal Performance Standard 21 CFR Part 1040.10. This device has no patient contacting materials and is intended to be used by trained personnel only. The output of the device is evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention in case of malfunction.
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K Number
K061302Device Name
DIGITAL PRINTER P6000D SERIES, MODEL P6000DU
Manufacturer
MITSUBISHI ELECTRIC CORPORATION KYOTO WORKS
Date Cleared
2006-06-23
(44 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
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Matched: '892.2040'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on the film/thermal paper. This device is not intended for mammography use.
Device Description
Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on 8x10" sized film/thermal paper. It does not incorporate laser scanning unit. The control unit processes and controls image data and performs control of the whole device. This device is not intended for mammography use.
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