BEUDAMED
    Product Code: OWN FDA class 2 21 CFR 876.1500

    Confocal Optical Imaging

    Gastroenterology, Urology

    The Confocal Optical Imaging device is used for the collection of light signals to enable visualization of cellular microstructures, with applications in gastroenterology and urology. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OWN, with regulation number 876.1500 under the Gastroenterology, Urology medical specialty.

    View on FDA
    510(k)s
    61
    FEI Numbers
    47
    Registration Numbers
    47
    Unique Applicants
    27
    Years Active
    15

    Basic Information

    Product Code
    OWN
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Collection of light signals for visualization of cellular microstructures.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 61 510(k) clearances via K numbers.

    K Number Device Name
    K242163 SmartSurgN Visualization System
    K254242 KARL STORZ ICG Imaging System with RUBINA® Lens
    K251852 cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
    K260108 L12 LED Light Source with AIM
    K253972 IMAGE1 (TC400US); X-to-4U Adapter (TC040)
    K251336 VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)
    K243711 Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);
    K243591 OPTOVISION Endoscopic Light Source Unit
    K241275 Histolog® Scanner (Hardware 2.4, Software 3.3)
    K233333 KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
    K232857 KARL STORZ ICG Imaging System
    K231854 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
    K231344 ActivSight Intraoperative Imaging System
    K230407 FloNavi Open Field Fluorescence Imaging System
    K230754 L12 LED Light Source with AIM
    K213943 SmartSurgN Visualization System
    K223020 VS3-Iridium System (VS3-IR)
    K221611 780 nm L11 LED Light Source with AIM
    K220477 Cellvizio 100 series system with confocal Miniprobes
    K210265 VS3 Iridium Sytem
    K212695 KARL STORZ ICG Imaging System
    K212322 Cellvizio I.V.E. system with Confocal Miniprobes
    K203550 ActivSight Intraoperative Imaging System
    K202925 KARL STORZ ICG Imaging System
    K202244 SPY-PHI System with SPY-PHI Fluorescence Assessment Software
    K201399 HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head
    K200542 Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
    K200737 SPY Portable Handheld Imaging (SPY-PHI) System
    K193416 Cellvizio I.V.E. with Confocal Miniprobes
    K191144 Cellvizio 100 Series System with Confocal Miniprobes
    K191851 VS3-IR
    K192292 L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable
    K192174 SPY Portable Handheld Imaging (SPY-PHI) System
    K191046 L10 LED Light Source with AIM, L11 LED Light Source with AIM
    K190729 SPY Portable Handheld Imaging (SPY-PHI) System
    K183453 VS3-IR
    K183640 Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
    K173866 Stryker AIM Light Source and SafeLight cable
    K172844 Cellvizio 100 Series System with Confocal Miniprobes
    K171345 Cellvizio 100 Series Systems with Confocal Miniprobes
    K171238 KARL STORZ ICG Imaging System
    K162882 KARL STORZ ICG Imaging System
    K162885 SPY Phi Open Field Handheld Fluorescence Imaging System
    K152583 KARL STORZ Endoscopic ICG Imaging System
    K160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
    K150831 Cellvizio 100 Series System with Confocal Miniprobes
    K152204 VS3-IR system
    K151593 Cellvizio 100 Series System with Confocal Miniprobes
    K143474 Artemis Hand Held Imaging System
    K150018 VS3-IR-MMS System
    K142310 Stryker Infrared Fluorescence (IRF) Imaging System
    K141358 CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
    K133466 CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
    K132475 FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
    K132389 CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED
    K124031 DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
    K123676 CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
    K122042 CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
    K120208 CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES
    K110480 PDE PHOTODYNAMIC EYE
    K111047 CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES

    FEI Numbers

    This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 47 registration numbers. Click on an entry to view related FDA registrations.