Confocal Optical Imaging
FDA product code OWN · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
Collection of light signals for visualization of cellular microstructures.
62510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Mauna Kea Technologies 16
- KARL STORZ Endoscopy-America, Inc. 6
- Stryker Corporation 6
- Karl Storz SE & CO. KG 4
- Visionsense, Ltd. 4
- Novadaq Technologies Ulc. (Now A Part of Stryker) 4
- Stryker Endoscopy 2
- SmartsurgN, Inc. 2
- Medtronic, Inc. 2
- Olympus Medical Systems Corp. 2
- Activ Surgical, Inc. 2
- LIMIS Development B.V. 1
- Optosurgical, LLC 1
- Samantree Medical SA 1
- Guangdong Optomedic Technologies, Inc. 1
- Novadaq Technologies, Inc. 1
- Quest Medical Imaging 1
- Fluoptics 1
- Daniel & Daniel Consulting 1
- Intuitive Surgical, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254180 | PerfusiX-ImagingOWN · Traditional | LIMIS Development B.V. | 07/24/2026SE |
| K242163 | SmartSurgN Visualization SystemOWN · Traditional | SmartsurgN, Inc. | 04/20/2026SE |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® LensOWN · Traditional | Karl Storz SE & CO. KG | 02/26/2026SE |
| K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)OWN · Traditional | VPIX Medical, Inc. | 02/13/2026SE |
| K260108 | L12 LED Light Source with AIMOWN · Special | Stryker Endoscopy | 02/12/2026SE |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040)OWN · Traditional | Karl Storz SE & CO. KG | 02/12/2026SE |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…OWN · Traditional | Olympus Medical Systems Corp. | 11/12/2025SE |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…OWN · Traditional | Wuxi Hisky Medical Technologies Co., Ltd. | 07/24/2025SE |
| K243591 | OPTOVISION Endoscopic Light Source UnitOWN · Traditional | Optosurgical, LLC | 02/19/2025SE |
| K241275 | Histolog® Scanner (Hardware 2.4, Software 3.3)OWN · Traditional | Samantree Medical SA | 08/19/2024SE |
| K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitOWN · Traditional | Karl Storz SE & CO. KG | 11/21/2023SE |
| K232857 | KARL STORZ ICG Imaging SystemOWN · Traditional | Karl Storz SE & CO. KG | 11/06/2023SE |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMOWN · Traditional | Stryker | 09/20/2023SE |
| K231344 | ActivSight Intraoperative Imaging SystemOWN · Traditional | Activ Surgical, Inc. | 08/02/2023SE |
| K230407 | FloNavi Open Field Fluorescence Imaging SystemOWN · Traditional | Guangdong Optomedic Technologies, Inc. | 07/17/2023SE |
| K230754 | L12 LED Light Source with AIMOWN · Special | Stryker | 04/11/2023SE |
| K213943 | SmartSurgN Visualization SystemOWN · Traditional | Smartsurgn Incorporated | 11/29/2022SE |
| K223020 | VS3-Iridium System (VS3-IR)OWN · Special | Visionsense, Ltd. | 10/28/2022SE |
| K221611 | 780 nm L11 LED Light Source with AIMOWN · Special | Stryker | 06/29/2022SE |
| K220477 | Cellvizio 100 series system with confocal MiniprobesOWN · Traditional | Mauna Kea Technologies | 04/11/2022SE |
| K210265 | VS3 Iridium SytemOWN · Traditional | Visionsense, Ltd. | 11/22/2021SE |
| K212695 | KARL STORZ ICG Imaging SystemOWN · Traditional | Karl Storz Endoscopy America | 11/15/2021SE |
| K212322 | Cellvizio I.V.E. system with Confocal MiniprobesOWN · Special | Mauna Kea Technologies | 08/18/2021SE |
| K203550 | ActivSight Intraoperative Imaging SystemOWN · Traditional | Activ Surgical, Inc. | 04/08/2021SE |
| K202925 | KARL STORZ ICG Imaging SystemOWN · Traditional | Karl Storz Endoscopy_America, Inc. | 12/17/2020SE |
| K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareOWN · Traditional | Novadaq Technologies Ulc. (Now A Part of Stryker) | 11/05/2020SE |
| K201399 | HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…OWN · Traditional | Karl Storz-Endoscopy-America, Inc. | 08/17/2020SE |
| K200542 | Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…OWN · Traditional | Olympus Medical Systems Corp. | 07/17/2020SE |
| K200737 | SPY Portable Handheld Imaging (SPY-PHI) SystemOWN · Traditional | Novadaq Technologies Ulc. (Now A Part of Stryker) | 05/21/2020SE |
| K193416 | Cellvizio I.V.E. with Confocal MiniprobesOWN · Traditional | Mauna Kea Technologies | 02/28/2020SE |
| K191144 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Traditional | Mauna Kea Technologies | 01/24/2020SE |
| K191851 | VS3-IROWN · Traditional | Medtronic | 11/25/2019SE |
| K192292 | L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableOWN · Traditional | Stryker | 11/19/2019SE |
| K192174 | SPY Portable Handheld Imaging (SPY-PHI) SystemOWN · Traditional | Novadaq Technologies Ulc. (Now A Part of Stryker) | 11/15/2019SE |
| K191046 | L10 LED Light Source with AIM, L11 LED Light Source with AIMOWN · Special | Stryker | 05/10/2019SE |
| K190729 | SPY Portable Handheld Imaging (SPY-PHI) SystemOWN · Special | Novadaq Technologies Ulc. (Now A Part of Stryker) | 04/19/2019SESD |
| K183453 | VS3-IROWN · Traditional | Medtronic | 03/04/2019SE |
| K183640 | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesOWN · Special | Mauna Kea Technologies | 02/22/2019SE |
| K173866 | Stryker AIM Light Source and SafeLight cableOWN · Special | Stryker | 01/18/2018SE |
| K172844 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Traditional | Mauna Kea Technologies | 12/15/2017SE |
| K171345 | Cellvizio 100 Series Systems with Confocal MiniprobesOWN · Traditional | Mauna Kea Technologies | 08/04/2017SE |
| K171238 | KARL STORZ ICG Imaging SystemOWN · Special | KARL STORZ Endoscopy-America, Inc. | 05/25/2017SE |
| K162882 | KARL STORZ ICG Imaging SystemOWN · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/26/2017SE |
| K162885 | SPY Phi Open Field Handheld Fluorescence Imaging SystemOWN · Traditional | Novadaq Technologies, Inc. | 01/11/2017SE |
| K152583 | KARL STORZ Endoscopic ICG Imaging SystemOWN · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/31/2016SE |
| K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesOWN · Special | Mauna Kea Technologies | 05/20/2016SE |
| K150831 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Traditional | Mauna Kea Technologies | 12/22/2015SE |
| K152204 | VS3-IR systemOWN · Traditional | Visionsense, Ltd. | 10/28/2015SE |
| K151593 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Traditional | Mauna Kea Technologies | 10/23/2015SE |
| K143474 | Artemis Hand Held Imaging SystemOWN · Traditional | Quest Medical Imaging | 06/30/2015SE |
| K150018 | VS3-IR-MMS SystemOWN · Traditional | Visionsense, Ltd. | 06/17/2015SE |
| K142310 | Stryker Infrared Fluorescence (IRF) Imaging SystemOWN · Traditional | Stryker Endoscopy | 12/02/2014SE |
| K141358 | Cellvizio 100 Series with System Confocal MiniprobesOWN · Traditional | Mauna Kea Technologies | 09/25/2014SE |
| K133466 | Cellvizio 100 Series System with Confocal Miniprobes (TM)OWN · Traditional | Mauna Kea Technologies | 07/25/2014SE |
| K132475 | Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control SystemOWN · Traditional | Fluoptics | 05/07/2014SE |
| K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…OWN · Traditional | Daniel & Daniel Consulting | 02/25/2014SE |
| K124031 | Da Vinci Fluorescence Imaging Vision SystemOWN · Traditional | Intuitive Surgical, Inc. | 09/13/2013SE |
| K123676 | Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesOWN · Traditional | Mauna Kea Technologies | 04/18/2013SE |
| K122042 | Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesOWN · Traditional | Mauna Kea Technologies | 09/04/2012SE |
| K120208 | Cellvizio 100 Series System and Cellvizio System with Confocal MiniprobesOWN · Special | Mauna Kea Technologies | 04/20/2012SE |
| K110480 | Pde Photodynamic EyeOWN · Traditional | Hamamatsu Photonics K.K. | 01/13/2012SE |
| K111047 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Special | Mauna Kea Technologies, Inc. | 08/08/2011SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0232-2025 Class II | Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029…Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2.… | Olympus Corporation of the Americas | 09/24/2024Open, Classified |
| Z-0282-2023 Class II | VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner)…Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of… | Visionsense, Ltd. | 10/17/2022Open, Classified |
| Z-0281-2023 Class II | VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm…XXX | Visionsense, Ltd. | 10/17/2022Open, Classified |
| Z-0280-2023 Class II | VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product…Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of… | Visionsense, Ltd. | 10/17/2022Open, Classified |