FDA 510(k) Applications for Medical Device Product Code "FET"
(Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K981827 | ANGIOLAZ, INC. | VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM | 07/28/1998 |
| K962024 | DEL MEDICAL SYSTEMS CORP. | S-57 VIDEO IMAGING SYSTEM | 07/09/1996 |
| K192286 | FUJIFILM Corporation | FUJIFILM EP-6000 Video Processor | 05/01/2020 |
| K150221 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. | EPX-4440HD and EPX-4400HD with FICE | 10/01/2015 |
| K163675 | FUJIFILM Medical System U.S.A., Inc. | Processor VP-7000, Light Source BL-7000 | 04/25/2017 |
| K180414 | FUJIFILM New Development U.S.A., Inc. | EPX-4440FN Digital Video Processor with Light Source | 05/24/2018 |
| K102466 | FUJINON, INC. | FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR | 05/25/2011 |
| K012660 | GIMMI GMBH | GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES | 12/20/2001 |
| K981856 | GREATBATCH SCIENTIFIC | MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) | 07/29/1998 |
| K013709 | HILL-ROM, INC. | HILL-ROM PRIMAVIEW MONITOR SYSTEM | 11/16/2001 |
| K080809 | INNOVATIVE ENDOSCOPY COMPONENTS, LLC. | IEC MEDSIGHT AND MEDBRIGHT | 08/11/2008 |
| K992469 | KARL STORZ ENDOSCOPY | KSEA SCBCOM | 10/15/1999 |
| K221174 | KARL STORZ Endoscopy America, Inc | Telepack + | 05/13/2022 |
| K160044 | KARL STORZ ENDOSCOPY AMERICA, INC. | Image1 SPIES System | 02/01/2016 |
| K193235 | Karl Storz Endoscopy America, Inc. | Telepack + | 12/20/2019 |
| K182696 | KARL STORZ Endoscopy-America, Inc | Telepack X LED | 11/20/2018 |
| K043324 | KARL STORZ ENDOSCOPY-AMERICA, INC. | AIDA WITH DICOM AND HL7 INTERFACE | 04/04/2005 |
| K070716 | KARL STORZ ENDOSCOPY-AMERICA, INC. | IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL | 05/31/2007 |
| K111997 | KARL STORZ ENDOSCOPY-AMERICA, INC. | IMAGE1 GI CCU MODEL 22203020-114 | 04/06/2012 |
| K201135 | Karl Storz Endoscopy-America, Inc. | Image1 S CCU, Image1 S 4U Camera Head | 09/01/2020 |
| K131953 | KARL STORZ ENDOSCOPY-AMERICA, INC. | IMAGE1 SPIES | 12/20/2013 |
| K031895 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA OPSERVER LAP | 09/23/2003 |
| K994348 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA SCB-RUI | 03/03/2000 |
| K003113 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA SCB-RUI SCO | 03/27/2001 |
| K994090 | KARL STORZ IMAGING, INC. | KARL STORZ AUTOCLAVABLE CAMERA HEAD | 02/04/2000 |
| K973252 | KARL STORZ IMAGING, INC. | KARL STORZ DIRECT COUPLED CAMERA HEAD | 11/24/1997 |
| K003325 | KARL STORZ IMAGING, INC. | KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM | 04/27/2001 |
| K032545 | MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) | ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250 | 09/02/2003 |
| K032544 | MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) | VP-1000; MED CAM 100; VP-3000A; MED CAM 300 | 09/02/2003 |
| K954451 | OLYMPUS AMERICA, INC. | EVIS 140 SYSTEM | 03/29/1996 |
| K971416 | OLYMPUS AMERICA, INC. | OLYMPUS OES OTV-S5C VIDEO SYSTEM | 07/16/1997 |
| K041494 | OLYMPUS CORPORATION | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 | 07/01/2004 |
| K172817 | Olympus Medical Systems Corp. | 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA | 10/17/2017 |
| K201200 | Olympus Medical Systems Corp. | Visera Elite II Video System Center | 07/22/2020 |
| K202646 | Olympus Medical Systems Corp. | Visera Elite II Video System Center | 10/29/2020 |
| K190449 | Olympus Medical Systems Corp. | Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head | 08/30/2019 |
| K102059 | OLYMPUS MEDICAL SYSTEMS CORPORATION | AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 | 10/08/2010 |
| K222584 | Olympus Medical Systems Corporation | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 | 04/26/2023 |
| K083155 | OLYMPUS MEDICAL SYSTEMS CORPORATION | HD CAMERA HEAD OTV-S7PROH-HD-L08E | 01/13/2009 |
| K113873 | PENTAX OF AMERICA, INC. | PENTAX EPK-I5020 VIDEO PROCESSOR | 06/22/2012 |
| K023659 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | 1-CCD ENDOCAM 5520 SYSTEM | 01/29/2003 |
| K964173 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ | 12/13/1996 |
| K130423 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 | 04/03/2013 |
| K211332 | Richard Wolf Medical Instruments Corporation | D Camera Controller | 10/01/2021 |
| K161204 | RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION | ENDOCAM Flex HD Camera System 5521 | 01/11/2017 |
| K180583 | Richard Wolf Medical Instruments Corporation | LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD | 06/28/2018 |
| K200617 | Richard Wolf Medical Instruments Corporation | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 | 06/23/2020 |
| K212808 | Richard Wolf Medical Instruments Corporation | Logic Hd camera head green, System green | 06/14/2022 |
| K992362 | SCHOELLY FIBEROPTIC, GMBH | FLEXISCOPE IQ 101 | 08/05/1999 |
| K090800 | SCHOELLY IMAGING, INC. | VS-100 ILLUMINATION AND IMAGING SYSTEM | 05/18/2009 |
| K003710 | SMITH & NEPHEW, INC. | DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905 | 02/02/2001 |
| K972540 | SOPRO | S-357 VIDEO IMAGING SYSTEM | 09/18/1997 |
| K973798 | SOPRO | S-357 VIDEO IMAGING SYSTEM | 12/03/1997 |
| K102949 | STI MEDICAL SYSTEMS, LLC | COLONOSCOPY ASSISTANT | 06/15/2011 |
| K081585 | VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS | ENDOSCOPY VIDEO CAMERA SYSTEM | 06/20/2008 |
| K020301 | VISTA MEDICAL TECHNOLOGIES, INC. | MODIFICATION TO VISTA STEREOSCOPE SYSTEM | 02/12/2002 |
| K971373 | VISTA MEDICAL TECHNOLOGIES, INC. | VISTA SINGLE CHIP VIDEO CAMERA | 05/20/1997 |
| K152109 | W.O.M. WORLD OF MEDICINE GmbH | HD-Camera HDC1000 | 10/13/2015 |
| K190648 | Zhuhai Pusen Medical Technology Co., Ltd. | Pusen Eview Medical Video Endoscope Image Processor | 03/29/2019 |
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