Endoscopic Video Imaging System/Component, Gastroenterology-Urology
FDA product code FET · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
101510(k) clearances
0PMA approvals
8recalls
Manufacturers
- KARL STORZ Endoscopy-America, Inc. 13
- Olympus Medical Systems Corp. 10
- Richard Wolf Medical Instruments Corp. 8
- Karl Storz Imaging, Inc. 5
- Precise Optics 3
- Olympus America, Inc. 3
- Fujifilm Corporation 3
- Fujinon, Inc. 3
- Marks & Murase 2
- Olympus Corp. 2
- Mgb Endoskopische Gerate GmbH (Berlin) 2
- Medical Laser, Inc. 2
- Sopro 2
- Umi, Inc. 2
- Vista Medical Technologies, Inc. 2
- Fujifilm Medical System U.S.A., Inc. 2
- Oktas 2
- Proverum Limited 1
- Nobles-Lai Engineering, Inc. 1
- Life-Tech Intl., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LBFET · Traditional | Olympus Medical Systems Corp. | 09/10/2026SE |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FET · Special | Fujifilm Corporation | 07/02/2026SE |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LBFET · Traditional | Olympus Medical Systems Corporation | 06/24/2026SE |
| K251734 | ProVee Video Processing Unit (PV-003)FET · Traditional | Proverum Limited | 09/24/2025SE |
| K250462 | UL UHD-Clear View 4K Camera System (UL-3Chip 4K)FET · Traditional | Univlabs Technologies Private Limited | 08/11/2025SE |
| K250204 | Endoscopic Camera SystemFET · Traditional | Shenzhen Sophway Technology Co., Ltd. | 07/01/2025SE |
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFET · Traditional | Fujifilm Corporation | 04/11/2025SE |
| K242067 | Visera Elite III Video System Center Olympus OTV-S700; Visera Elite III LED Light Source…FET · Traditional | Olympus Corporations of the Americas | 04/02/2025SE |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F)FET · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 02/07/2025SE |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)FET · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 10/22/2024SE |
| K241371 | Visera S Video System Center Olympus OTV-S500 (Olympus OTV-S500)FET · Traditional | Olympus Medical Systems Corporation | 07/03/2024SE |
| K222584 | Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I…FET · Traditional | Olympus Medical Systems Corporation | 04/26/2023SE |
| K212808 | Logic Hd camera head green, System greenFET · Traditional | Richard Wolf Medical Instruments Corporation | 06/14/2022SE |
| K221174 | Telepack +FET · Special | Karl Storz Endoscopy America, Inc. | 05/13/2022SE |
| K211332 | D Camera ControllerFET · Traditional | Richard Wolf Medical Instruments Corporation | 10/01/2021SE |
| K202646 | Visera Elite II Video System CenterFET · Special | Olympus Medical Systems Corp. | 10/29/2020SE |
| K201135 | Image1 S CCU, Image1 S 4U Camera HeadFET · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/01/2020SE |
| K201200 | Visera Elite II Video System CenterFET · Special | Olympus Medical Systems Corp. | 07/22/2020SE |
| K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller…FET · Traditional | Richard Wolf Medical Instruments Corporation | 06/23/2020SE |
| K192286 | FUJIFILM EP-6000 Video ProcessorFET · Traditional | Fujifilm Corporation | 05/01/2020SE |
| K193235 | Telepack +FET · Special | Karl Storz Endoscopy America, Inc. | 12/20/2019SE |
| K190449 | Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head…FET · Traditional | Olympus Medical Systems Corp. | 08/30/2019SE |
| K190648 | Pusen Eview Medical Video Endoscope Image ProcessorFET · Traditional | Zhuhai Pusen Medical Technology Co., Ltd. | 03/29/2019SE |
| K182696 | Telepack X LEDFET · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/20/2018SE |
| K180583 | Logic 4K Camera Controller, Logic 4K Camera HeadFET · Traditional | Richard Wolf Medical Instruments Corporation | 06/28/2018SE |
| K180414 | EPX-4440FN Digital Video Processor with Light SourceFET · Traditional | Fujifilm New Development U.S.A., Inc. | 05/24/2018SE |
| K172817 | 4K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head Olympus CH-S400-XZ-EAFET · Special | Olympus Medical Systems Corp. | 10/17/2017SE |
| K163675 | Processor VP-7000, Light Source BL-7000FET · Traditional | Fujifilm Medical System U.S.A., Inc. | 04/25/2017SE |
| K161204 | ENDOCAM Flex HD Camera System 5521FET · Traditional | Richard Wolf Medical Instruments Corporation | 01/11/2017SE |
| K160044 | Image1 SPIES SystemFET · Special | Karl Storz Endoscopy America, Inc. | 02/01/2016SE |
| K152109 | HD-Camera HDC1000FET · Traditional | W.O.M. World of Medicine GmbH | 10/13/2015SE |
| K150221 | EPX-4440HD and EPX-4400HD with FICEFET · Traditional | Fujifilm Medical System U.S.A., Inc. | 10/01/2015SE |
| K131953 | IMAGE1 SpiesFET · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/20/2013SE |
| K130423 | The Richard Wolf Endocam Logic HD Camera System 5525FET · Traditional | Richard Wolf Medical Instruments Corp. | 04/03/2013SE |
| K113873 | Pentax EPK-I5020 Video ProcessorFET · Traditional | Pentax of America, Inc. | 06/22/2012SE |
| K111997 | IMAGE1 Gi Ccu Model 22203020-114FET · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/06/2012SE |
| K102949 | Colonoscopy AssistantFET · Traditional | Sti Medical Systems, LLC | 06/15/2011SE |
| K102466 | Fujinon EPX-4440HD Digital Video ProcessorFET · Traditional | Fujinon, Inc. | 05/25/2011SE |
| K102059 | Autoclavable Camer Head Model OTV-Y0017FET · Traditional | Olympus Medical Systems Corporation | 10/08/2010SE |
| K090800 | VS-100 Illumination and Imaging SystemFET · Traditional | Schoelly Imaging, Inc. | 05/18/2009SE |
| K083155 | HD Camera Head OTV-S7PROH-HD-L08EFET · Traditional | Olympus Medical Systems Corporation | 01/13/2009SE |
| K080809 | Iec Medsight and MedbrightFET · Traditional | Innovative Endoscopy Components, LLC | 08/11/2008SE |
| K081585 | Endoscopy Video Camera SystemFET · Special | Vision Systems Group, A Division of Viking Systems | 06/20/2008SE |
| K070716 | Image 1 Video Imaging System with Optional Insufflators ControlFET · Special | KARL STORZ Endoscopy-America, Inc. | 05/31/2007SE |
| K043324 | Aida with Dicom and HL7 InterfaceFET · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/04/2005SE |
| K041494 | Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery UCES-2)…FET · Special | Olympus Corporation | 07/01/2004SE |
| K031895 | Ksea Opserver LapFET · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/23/2003SE |
| K032545 | Endoscopic Light Source LS-3000X; LS-1800XG/MED Light X 180; LS-2500H/MED Light H 250FET · Traditional | Mgb Endoskopische Gerate GmbH (Berlin) | 09/02/2003SE |
| K032544 | VP-1000; Med Cam 100; VP-3000A; Med Cam 300FET · Traditional | Mgb Endoskopische Gerate GmbH (Berlin) | 09/02/2003SE |
| K023659 | 1-CCD Endocam 5520 SystemFET · Traditional | Richard Wolf Medical Instruments Corp. | 01/29/2003SE |
| K020301 | Modification to Vista Stereoscope SystemFET · Special | Vista Medical Technologies, Inc. | 02/12/2002SE |
| K012660 | Gimmi'Alpha' Endoscopes & AccessoriesFET · Abbreviated | Gimmi GmbH | 12/20/2001SE |
| K013709 | Hill-Rom Primaview Monitor SystemFET · Traditional | Hill-Rom, Inc. | 11/16/2001SE |
| K003325 | Ksi's New Camera Architecture (Nca) Video Imaging SystemFET · Traditional | Karl Storz Imaging, Inc. | 04/27/2001SE |
| K003113 | Ksea Scb-Rui ScoFET · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/27/2001SE |
| K003710 | Dyonics Vision 337 Autoclavable Camera Head Model 7209048; Dyonics Autoclavable Camera…FET · Traditional | Smith & Nephew, Inc. | 02/02/2001SE |
| K994348 | Ksea Scb-RuiFET · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/03/2000SE |
| K994090 | Karl Storz Autoclavable Camera HeadFET · Traditional | Karl Storz Imaging, Inc. | 02/04/2000SE |
| K992469 | Ksea ScbcomFET · Traditional | Karl Storz Endoscopy | 10/15/1999SE |
| K992362 | Flexiscope Iq 101FET · Traditional | Schoelly Fiberoptic GmbH | 08/05/1999SE |
| K981856 | Magna-Cam (MR Endoscopic Camera) and Magna-Pix ( MR Color Video Monitor)FET · Traditional | Greatbatch Scientific | 07/29/1998SE |
| K981827 | Ves 0281-M Complete Video Endoscopic Video SystemFET · Traditional | Angiolaz, Inc. | 07/28/1998SE |
| K973798 | S-357 Video Imaging SystemFET · Traditional | Sopro | 12/03/1997SE |
| K973252 | Karl Storz Direct Coupled Camera HeadFET · Traditional | Karl Storz Imaging, Inc. | 11/24/1997SE |
| K972540 | S-357 Video Imaging SystemFET · Traditional | Sopro | 09/18/1997SE |
| K971416 | Olympus Oes OTV-S5C Video SystemFET · Traditional | Olympus America, Inc. | 07/16/1997SE |
| K971373 | Vista Single Chip Video CameraFET · Traditional | Vista Medical Technologies, Inc. | 05/20/1997SE |
| K964173 | C-Mount Objective Lens F = 17 MM, Steam-Sterilizable: Model 85 261.172, C-Mount…FET · Traditional | Richard Wolf Medical Instruments Corp. | 12/13/1996SE |
| K962024 | S-57 Video Imaging SystemFET · Traditional | Del Medical Systems Corp. | 07/09/1996SE |
| K954451 | Evis 140 SystemFET · Traditional | Olympus America, Inc. | 03/29/1996SE |
| K954734 | The Tulip LCI-200 Illumination & Imaging System (Modification)FET · Traditional | The Tulip Mfg. Co. | 11/14/1995SE |
| K952482 | Ksea Reverse VideoFET · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/23/1995SE |
| K950417 | EPX-310 Video Processor (Endoscopy)FET · Traditional | Marks & Murase | 07/21/1995SE |
| K950975 | Karl Storz Endovision Twinvideo (Digital Picture-In-Picture Processor) Accessory for…FET · Traditional | Karl Storz Imaging, Inc. | 05/11/1995SE |
| K950974 | Karl Storz Endovision Digivideo (Digital Image Processor) Accessory for Color Television…FET · Traditional | Karl Storz Imaging, Inc. | 05/11/1995SE |
| K944620 | Series 400 Gastroenterology SystemFET · Traditional | Marks & Murase | 04/27/1995SE |
| K944759 | 200 Series Gastro-Intestinal Video SystemFET · Traditional | Fujinon, Inc. | 04/11/1995SE |
| K944254 | Oktas Stereo Viewing SystemFET · Traditional | Oktas | 11/30/1994SE |
| K944081 | Olympus Switching Unit Model SU-1FET · Traditional | Olympus America, Inc. | 11/14/1994SE |
| K940283 | Karl Storz Endovision Urocam/HysterocamFET · Traditional | Medical Concepts, Inc. | 09/28/1994SE |
| K941919 | Oktas Endoscopy Video Camera SystemFET · Traditional | Oktas | 06/17/1994SE |
| K942141 | Eidolon Endoscope CouplerFET · Traditional | Eidolon Corp. | 05/27/1994SE |
| K932312 | Fujinon Video Laparoscope -- ModifiedFET · Traditional | Fujinon, Inc. | 02/16/1994SE |
| K934918 | EPM-3300 Video ProcessorFET · Traditional | Pentax Precision Instrument Corp. | 02/07/1994SE |
| K934623 | Endoscopic Video System and Endoscopic Video CameraFET · Traditional | Endomedix | 12/02/1993SE |
| K920026 | Nobles-Lai Imaging SystemFET · Traditional | Nobles-Lai Engineering, Inc. | 07/28/1992SESK |
| K912447 | Series 5000 Endoscope Console Models 5100 and 5200FET · Traditional | Medical Laser, Inc. | 09/27/1991SE |
| K912531 | Imd Multicam 1000/2000 Video Camera SystemsFET · Traditional | Innovative Medical Devices, Inc. | 09/04/1991SE |
| K911485 | Color Video CameraFET · Traditional | United States Endoscopy Group, Inc. | 08/14/1991SE |
| K903459 | Precision Optics Endoscope AdapterFET · Traditional | Precise Optics | 10/26/1990SE |
| K903458 | Precision Optics Image CouplerFET · Traditional | Precise Optics | 10/19/1990SE |
| K903457 | Precision Optics Image Beamsplitter (Coupler)FET · Traditional | Precise Optics | 10/19/1990SE |
| K900380 | Medilase 5010 Endoscope ConsoleFET · Traditional | Medical Laser, Inc. | 05/15/1990SE |
| K870680 | Optical Console(Tm) and Optical Catheter(Tm)FET · Traditional | Medline Industries, Inc. | 04/17/1987SE |
| K853585 | Olympus Evs-Endoscopic Video Image & Data SysFET · Traditional | Olympus Corp. | 01/21/1986SE |
| K843198 | Video Urodynamics Sys 1906B-Y & 1906C-YFET · Traditional | Life-Tech Intl., Inc. | 10/04/1984SE |
| K831412 | CRM-100 Color Video CameraFET · Traditional | Umi, Inc. | 06/03/1983SE |
| K830924 | CRM-114 Color Video CameraFET · Traditional | Umi, Inc. | 04/18/1983SE |
| K822959 | Endoscopic VideosystemFET · Traditional | Eder Instrument Co, Inc. | 10/22/1982SE |
| K820624 | Syn-Optics #5200FET · Traditional | Syn-Optics | 04/01/1982SE |
| K810393 | Endoscopic Closed Circuit Color TV Syst.FET · Traditional | Keymed, Inc. | 03/02/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0181-2025 Class II | Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100It was discovered during device performance testing that the CCD imaging sensors were programmed with the… | Olympus Corporation of the Americas | 08/21/2024Open, Classified |
| Z-0346-2024 Class II | Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other…Channel air drying process was not validated, and that a small percentage of scopes returned to customers… | Aizu Olympus Co., Ltd. | 09/25/2023Open, Classified |
| Z-0329-2024 Class II | Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract…Channel air drying process was not validated, and that a small percentage of scopes returned to customers… | Aizu Olympus Co., Ltd. | 09/25/2023Open, Classified |
| Z-2270-2018 Class II | Olympus JF-160F duodenoscopes (Model NumberJF-160F)Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additional recess… | Olympus Corporation of the Americas | 05/11/2018Terminated |
| Z-2269-2018 Class II | Olympus JF-140F duodenoscopes (Model NumberJF-140F)Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result… | Olympus Corporation of the Americas | 05/11/2018Terminated |
| Z-2134-2016 Class II | Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with…Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are… | Karl Storz Endoscopy | 06/20/2016Terminated |
| Z-2806-2015 Class II | Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in…The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant… | Fujifilm Medical Systems U.S.A., Inc. | 06/30/2015Terminated |
| Z-2805-2015 Class II | Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant… | Fujifilm Medical Systems U.S.A., Inc. | 06/30/2015Terminated |