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510(k) Data Aggregation

    K Number
    K180732
    Device Name
    MiroCam Capsule Endoscope System
    Manufacturer
    IntroMedic Co., Ltd.
    Date Cleared
    2018-11-08

    (233 days)

    Product Code
    NEZ
    Regulation Number
    876.1300
    Why did this record match?
    Applicant Name (Manufacturer) :

    IntroMedic Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. - It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy. It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for adults and children from two years of age. The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.
    Device Description
    The MiroCam® Capsule Endoscope System is comprised of the following core components: - MiroCam® Capsule: MC1600-B - MiroCam® Receiver: MR2000 - Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L) - MiroView™ Software: MiroView™ U 4.0 The general usage workflow of the MiroCam® system is as follows, the MiroCam® capsule captures images of the GI tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the Commercial PC and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.
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    K Number
    K170438
    Device Name
    MiroCam Capsule Endoscope System
    Manufacturer
    IntroMedic Co., Ltd.
    Date Cleared
    2018-01-30

    (351 days)

    Product Code
    NEZ
    Regulation Number
    876.1300
    Why did this record match?
    Applicant Name (Manufacturer) :

    IntroMedic Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. - It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. - It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy. It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for adults only. The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.
    Device Description
    The MiroCam® Capsule Endoscope System is comprised of the following core components: - MiroCam® Capsule: MC2000-B - MiroCam® Receiver: MR2000 - Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L) - MiroView™ Software: MiroView™ U 4.0 The MiroCam® capsule captures images of the GI tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the Commercial PC and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.
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