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510(k) Data Aggregation

    K Number
    K111167
    Device Name
    XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
    Manufacturer
    VELOPEX INTERNATIONAL, INC.
    Date Cleared
    2011-08-18

    (114 days)

    Product Code
    IXW
    Regulation Number
    892.1900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ExtraXtender Film Processor is an automatic film processor used by dental offices to develop X-ray films. The Extra Xtender processes all film sizes of intra-oral and extra oral film. High quality archivable radiographs are delivered dry in 5 minutes. Films may be viewed wet after 2 1/2 minutes. The Sprint Film Processor is an automatic film processor used by dental offices to develop xray films. The Sprint Film Processor processes all sizes of intra-oral film. Films may be viewed wet after 2 1/2 minutes.
    Device Description
    Automatic Film processor
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    K Number
    K093355
    Device Name
    PCR ELEVA 1.2
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Date Cleared
    2010-01-08

    (73 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PCR Eleva System is a digital film processing system for reading and then digitizing X-ray images from reusable imaging plates which have been exposed in conventional radiographic examination devices. The digitized X-ray images can then be viewed, stored, post-processed and printed. The PCR Eleva system can be used in all conventional RAD/RF examination situations, except for mammography. PCR is suitable for routine RAD exams as well as specialist areas, like intensive care units, trauma departments and pediatric departments.
    Device Description
    A PCR Eleva consists of one or more workspots with PCR Eleva Software and one or more image plate readers. All components are connected via standard ethernet. The system complies with the ACR/NEMA DICOM Version 3 Digital Image Communication in Medicine Standard. Imaging plates are exposed via conventional X-Ray devices. The imaging plates used in PCR systems are coated with a luminescent material which acts as an x-ray detector. It stores the x-ray image in the form of excited charge carriers. An exposed imaging plate is loaded into the image reader of the PCR Eleva system and the image stored on the imaging plate is scanned with a laser and converted to digital data. The digital X-ray image data is then routed to the Eleva workstation for image processing, viewing, storing and/or printing to film if the workstations are connected to a compatible laser imager. The Eleva Workspot is also used for the scheduling of patients and exams. The Eleva Workstation consists of a PC, a keyboard, a monitor, and an optional bar-code reader.
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    K Number
    K093503
    Device Name
    INTRAX FILM PROCESSOR
    Manufacturer
    VELOPEX INTERNATIONAL, INC.
    Date Cleared
    2010-01-06

    (55 days)

    Product Code
    IXW
    Regulation Number
    892.1900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntraX Film Processor is an Automatic film processor used by dental offices to develop x-ray films. all sizes of intra - oral film .
    Device Description
    IntraX Film Processor Trade Name: IntraX Film Processor Common Name: Automatic Film processor Classification name: Processor, Radiographic-Film, Automatic Device Class 2 Regulation Number: 892.1900
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    K Number
    K091628
    Device Name
    OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
    Manufacturer
    PROTEC GMBH & CO. KG
    Date Cleared
    2009-08-21

    (78 days)

    Product Code
    IXW
    Regulation Number
    892.1900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX are all Automatic X-Ray Film Processors (Regulation No. 892.1900). The devices mentioned above are intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films. This may be used in all general radiographic, diagnostic imaging procedures.
    Device Description
    Due to the precise roller transport system, both sheet and roller films can be processed. The automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed, fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperature-regulated, circulated and automatically replenished. The feed width of the OPTIMAX®, OPTIMAX® 2010 and ECOMAX™ is 35 cm, the bigger COMPACT™ 2 has 45 cm feed with. The smallest film format of all processors is 10*10 cm. The photographic processing (developing) technique employed by the Automatic X-Ray Film Processor is the same as the predicate device. The film medium is mechanically transported for immersion in two chemical baths (developer and fixer), is rinsed in water, dried, and then ejected for viewing. The processors use mechanical rollers for transportation, the solutions are temperature-regulated, circulated and automatically replenished, and same additional functions (anti-crystallization cycle, stand-by mode). All are controlled by an integrated software.
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    K Number
    K052661
    Device Name
    QUIX DIGITAL RADIOGRAPHIC UPGRADE
    Manufacturer
    EDGE MEDICAL DEVICES LTD.
    Date Cleared
    2006-06-07

    (253 days)

    Product Code
    MQB
    Regulation Number
    892.1680
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography.
    Device Description
    The Quix Digital Radiography Upgrade enables a conventional film-screen X-ray system to perform digital radiography exams by replacing the film-screen and the film-screen bucky with a digital bucky and operator console. The digital bucky incorporates a selenium-based flat panel detector with 16" x 17" imaging area. Images are displayed in approximately 10 seconds after exposure over a wide range of dose settings. The operator console provides local image storage and communicates with other network devices using DICOM 3.0 protocols.
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    K Number
    K024342
    Device Name
    RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
    Manufacturer
    DAITO CO., LTD.
    Date Cleared
    2003-04-23

    (117 days)

    Product Code
    IXW
    Regulation Number
    892.1900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Developing exposed x-ray film.
    Device Description
    Designed solely for processing of radiographed films, by roller transport system and by use of developer/fixer solutions(that are to be locally obtained).
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    K Number
    K023801
    Device Name
    FILM PROCESSOR, MODEL LIFE RAY PRO 1000
    Manufacturer
    S.A.I.E.P. S.R.L.
    Date Cleared
    2003-02-12

    (90 days)

    Product Code
    IXW
    Regulation Number
    892.1900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Automatic Radiographic Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films. This may be used in all general radiographic, diagnostic imaging procedures.
    Device Description
    Due to the precise roller transport system, both sheet and roller films can be processed. The Automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed , fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperature-regulated, circulated and automatically replenished. The feed with of the LifeRay PRO 1000 is 35cm, the smallest film format of the processor is 10x10cm.
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    K Number
    K023825
    Device Name
    FILM PROCESSOR, MODEL LIFE RAY PRO 2500
    Manufacturer
    S.A.I.E.P. S.R.L.
    Date Cleared
    2003-02-12

    (90 days)

    Product Code
    IXW
    Regulation Number
    892.1900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Automatic Radiographic Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films. This may be used in all general radiographic, diagnostic imaging procedures.
    Device Description
    Due to the precise roller transport system, both sheet and roller films can be processed. The Automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed , fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperatureregulated, circulated and automatically replenished. The feed with of the LifeRay PRO 2500 is 35cm, the smallest film format of the processor is 10x10cm.
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    K Number
    K023613
    Device Name
    AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
    Manufacturer
    ALPHATEK CORP.
    Date Cleared
    2003-01-23

    (87 days)

    Product Code
    IXW
    Regulation Number
    892.1900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE Ax200 is intended to develop medical x-ray film.
    Device Description
    AX200 Automatic X-Ray Film Processor Model # 6586.03
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    K Number
    K022154
    Device Name
    LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
    Manufacturer
    FISCHER INDUSTRIES, INC.
    Date Cleared
    2002-09-30

    (90 days)

    Product Code
    IXW
    Regulation Number
    892.1900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Level 356 X-Ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to develope, fix, wash, and dry automatically and continuously film exposed for medical and dental purposes. This is the sole purpose of this device.
    Device Description
    Automatic Radiographic Film Processor. This film processor is operates like most predicate devices in that it uses a series of transport rollers to pull film through a series of open developer solution, fixer solution, and wash water tanks. Developer and fixer solution temperature is controlled automatically by a computer board. No plumbing is required.
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