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510(k) Data Aggregation

    K Number
    K260185

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-02-18

    (28 days)

    Product Code
    Regulation Number
    876.1500
    Age Range
    0 - 150
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    1688 Camera 4K Camera System with Advanced Imaging Modality:

    The 1688 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery, spine surgery, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1688 4K Camera System with Advanced Imaging Modality is indicated for adults and pediatric patients.

    A few examples of the more common endoscope surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node detection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

    1788 Camera 4K Camera System with Advanced Imaging Modality:

    The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery, spine surgery, and plastic surgery whenever a laparoscope/ endoscope/arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients.

    A few examples of the more common endoscope surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node detection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

    Device Description

    Stryker's Advanced Imaging Modality (AIM) System includes the 1688 4K Camera System with AIM and 1788 4K Camera System with AIM, which are endoscopic camera systems that produces live video in the surgical field during surgical endoscopic procedures.

    The 1688 4K Camera System with AIM is sensitive in the visible white light and infrared spectrums. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1788 4K Camera System with AIM is sensitive in the visible white light, infrared spectrums and short blue spectrums. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1688 and 1788 4K Camera Systems consist of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.

    AI/ML Overview

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