FDA 510(k) Applications for Medical Device Product Code "OWN"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K231344 | Activ Surgical Inc. | ActivSight Intraoperative Imaging System | 08/02/2023 |
| K203550 | Activ Surgical, Inc. | ActivSight Intraoperative Imaging System | 04/08/2021 |
| K132389 | DANIEL & DANIEL CONSULTING | CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED | 02/25/2014 |
| K132475 | FLUOPTICS | FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM | 05/07/2014 |
| K230407 | Guangdong OptoMedic Technologies, Inc. | FloNavi Open Field Fluorescence Imaging System | 07/17/2023 |
| K110480 | HAMAMATSU PHOTONICS, K.K. | PDE PHOTODYNAMIC EYE | 01/13/2012 |
| K124031 | INTUITIVE SURGICAL, INC. | DA VINCI FLUORESCENCE IMAGING VISION SYSTEM | 09/13/2013 |
| K212695 | KARL STORZ Endoscopy America | KARL STORZ ICG Imaging System | 11/15/2021 |
| K202925 | KARL STORZ Endoscopy_America, Inc. | KARL STORZ ICG Imaging System | 12/17/2020 |
| K171238 | Karl Storz Endoscopy- America, Inc. | KARL STORZ ICG Imaging System | 05/25/2017 |
| K152583 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ Endoscopic ICG Imaging System | 05/31/2016 |
| K162882 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ ICG Imaging System | 01/26/2017 |
| K201399 | Karl Storz-Endoscopy-America, Inc. | 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 Opt | 08/17/2020 |
| K122042 | MAUNA KEA TECHNOLOGIES | CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES | 09/04/2012 |
| K123676 | MAUNA KEA TECHNOLOGIES | CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES | 04/18/2013 |
| K183640 | Mauna Kea Technologies | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes | 02/22/2019 |
| K120208 | MAUNA KEA TECHNOLOGIES | CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES | 04/20/2012 |
| K151593 | MAUNA KEA TECHNOLOGIES | Cellvizio 100 Series System with Confocal Miniprobes | 10/23/2015 |
| K172844 | Mauna Kea Technologies | Cellvizio 100 Series System with Confocal Miniprobes | 12/15/2017 |
| K220477 | Mauna Kea Technologies | Cellvizio 100 series system with confocal Miniprobes | 04/11/2022 |
| K191144 | Mauna Kea Technologies | Cellvizio 100 Series System with Confocal Miniprobes | 01/24/2020 |
| K150831 | MAUNA KEA TECHNOLOGIES | Cellvizio 100 Series System with Confocal Miniprobes | 12/22/2015 |
| K133466 | MAUNA KEA TECHNOLOGIES | CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) | 07/25/2014 |
| K171345 | Mauna Kea Technologies | Cellvizio 100 Series Systems with Confocal Miniprobes | 08/04/2017 |
| K141358 | MAUNA KEA TECHNOLOGIES | CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES | 09/25/2014 |
| K212322 | Mauna Kea Technologies | Cellvizio I.V.E. system with Confocal Miniprobes | 08/18/2021 |
| K193416 | Mauna Kea Technologies | Cellvizio I.V.E. with Confocal Miniprobes | 02/28/2020 |
| K160416 | MAUNA KEA TECHNOLOGIES | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes | 05/20/2016 |
| K111047 | MAUNA KEA TECHNOLOGIES INC. | CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES | 08/08/2011 |
| K183453 | Medtronic | VS3-IR | 03/04/2019 |
| K191851 | Medtronic | VS3-IR | 11/25/2019 |
| K162885 | NOVADAQ TECHNOLOGIES INC. | SPY Phi Open Field Handheld Fluorescence Imaging System | 01/11/2017 |
| K202244 | Novadaq Technologies ULC (now a part of Stryker) | SPY-PHI System with SPY-PHI Fluorescence Assessment Software | 11/05/2020 |
| K190729 | Novadaq Technologies ULC. (now a part of Stryker) | SPY Portable Handheld Imaging (SPY-PHI) System | 04/19/2019 |
| K192174 | Novadaq Technologies ULC. (now a part of Stryker) | SPY Portable Handheld Imaging (SPY-PHI) System | 11/15/2019 |
| K200737 | Novadaq Technologies ULC. (now a part of Stryker) | SPY Portable Handheld Imaging (SPY-PHI) System | 05/21/2020 |
| K200542 | Olympus Medical Systems Corp. | 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 | 07/17/2020 |
| K143474 | QUEST MEDICAL IMAGING | Artemis Hand Held Imaging System | 06/30/2015 |
| K213943 | SmartSurgN Incorporated | SmartSurgN Visualization System | 11/29/2022 |
| K231854 | Stryker | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM | 09/20/2023 |
| K221611 | Stryker | 780 nm L11 LED Light Source with AIM | 06/29/2022 |
| K191046 | Stryker | L10 LED Light Source with AIM, L11 LED Light Source with AIM | 05/10/2019 |
| K192292 | Stryker | L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable | 11/19/2019 |
| K230754 | Stryker | L12 LED Light Source with AIM | 04/11/2023 |
| K173866 | Stryker | Stryker AIM Light Source and SafeLight cable | 01/18/2018 |
| K142310 | Stryker Endoscopy | Stryker Infrared Fluorescence (IRF) Imaging System | 12/02/2014 |
| K152204 | VISIONSENSE LTD | VS3-IR system | 10/28/2015 |
| K210265 | Visionsense Ltd. | VS3 Iridium Sytem | 11/22/2021 |
| K150018 | Visionsense Ltd. | VS3-IR-MMS System | 06/17/2015 |
| K223020 | Visionsense Ltd. | VS3-Iridium System (VS3-IR) | 10/28/2022 |
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