LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K954345
    Why did this record match?
    Device Name :

    OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    This document, a 510(k) summary for PROTEC's Automatic X-Ray Film Processor, describes the device and its intended use, but does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document focuses on demonstrating substantial equivalence to a predicate device (DOOSAN DSP 3800 Automatic X-Ray Film Processor) based on:

    1. Same intended use
    2. Same target user group
    3. Same technological characteristics

    Therefore, I cannot provide the requested table and study details. The information necessary to construct such a response is not present within the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1