Endoscopic Video Imaging System/Component, Gastroenterology-Urology
FDA product code FET · 99 cleared devices
Class 2
Gastroenterology, Urology
- Regulation
- 21 CFR 876.1500
- Review panel
- GU
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1981-03-02 – 2026-09-10
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
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VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA
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VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
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2023-04-26
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
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2022-06-14
Logic Hd camera head green, System green
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2022-05-13
Telepack +
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2021-10-01
D Camera Controller
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2020-10-29
Visera Elite II Video System Center
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2020-09-01
Image1 S CCU, Image1 S 4U Camera Head
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2020-07-22
Visera Elite II Video System Center
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2020-06-23
Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
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2020-05-01
FUJIFILM EP-6000 Video Processor
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2019-12-20
Telepack +
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2019-08-30
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
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2019-03-29
Pusen Eview Medical Video Endoscope Image Processor
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2018-11-20
Telepack X LED
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2018-06-28
LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
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2018-05-24
EPX-4440FN Digital Video Processor with Light Source
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2017-10-17
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
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2017-04-25
Processor VP-7000, Light Source BL-7000
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2017-01-11
ENDOCAM Flex HD Camera System 5521
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2016-02-01
Image1 SPIES System
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2013-12-20
IMAGE1 SPIES
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2013-04-03
THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
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2012-06-22
PENTAX EPK-I5020 VIDEO PROCESSOR
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2012-04-06
IMAGE1 GI CCU MODEL 22203020-114
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FET
2011-06-15
COLONOSCOPY ASSISTANT
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FET
2011-05-25
FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
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FET
2010-10-08
AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
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2009-05-18
VS-100 ILLUMINATION AND IMAGING SYSTEM
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2009-01-13
HD CAMERA HEAD OTV-S7PROH-HD-L08E
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FET
2008-08-11
IEC MEDSIGHT AND MEDBRIGHT
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FET
2008-06-20
ENDOSCOPY VIDEO CAMERA SYSTEM
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FET
2007-05-31
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
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FET
2005-04-04
AIDA WITH DICOM AND HL7 INTERFACE
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FET
2004-07-01
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2
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FET
2003-09-23
KSEA OPSERVER LAP
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FET
2003-09-02
ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250
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FET
2003-09-02
VP-1000; MED CAM 100; VP-3000A; MED CAM 300
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FET
2003-01-29
1-CCD ENDOCAM 5520 SYSTEM
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FET
2002-02-12
MODIFICATION TO VISTA STEREOSCOPE SYSTEM
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FET
2001-12-20
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
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FET
2001-11-16
HILL-ROM PRIMAVIEW MONITOR SYSTEM
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FET
2001-04-27
KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
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FET
2001-03-27
KSEA SCB-RUI SCO
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FET
2001-02-02
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905
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FET
2000-03-03
KSEA SCB-RUI
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FET
2000-02-04
KARL STORZ AUTOCLAVABLE CAMERA HEAD
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FET
1999-10-15
KSEA SCBCOM
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FET
1999-08-05
FLEXISCOPE IQ 101
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FET
1998-07-29
MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)
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FET
1998-07-28
VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM
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FET
1997-12-03
S-357 VIDEO IMAGING SYSTEM
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FET
1997-11-24
KARL STORZ DIRECT COUPLED CAMERA HEAD
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FET
1997-09-18
S-357 VIDEO IMAGING SYSTEM
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FET
1997-07-16
OLYMPUS OES OTV-S5C VIDEO SYSTEM
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FET
1997-05-20
VISTA SINGLE CHIP VIDEO CAMERA
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FET
1996-12-13
C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ
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FET
1996-07-09
S-57 VIDEO IMAGING SYSTEM
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FET
1996-03-29
EVIS 140 SYSTEM
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FET
1995-11-14
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION)
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FET
1995-10-23
KSEA REVERSE VIDEO
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FET
1995-07-21
EPX-310 VIDEO PROCESSOR (ENDOSCOPY)
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FET
1995-05-11
KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS
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FET
1995-05-11
KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS
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FET
1995-04-27
SERIES 400 GASTROENTEROLOGY SYSTEM
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FET
1995-04-11
200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM
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FET
1994-11-30
OKTAS STEREO VIEWING SYSTEM
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FET
1994-11-14
OLYMPUS SWITCHING UNIT MODEL SU-1
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FET
1994-09-28
KARL STORZ ENDOVISION UROCAM/HYSTEROCAM
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FET
1994-06-17
OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM
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FET
1994-05-27
EIDOLON ENDOSCOPE COUPLER
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FET
1994-02-16
FUJINON VIDEO LAPAROSCOPE -- MODIFIED
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FET
1994-02-07
EPM-3300 VIDEO PROCESSOR
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FET
1993-12-02
ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA
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FET
1992-07-28
NOBLES-LAI IMAGING SYSTEM
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FET
1991-09-27
SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200
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FET
1991-09-04
IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS
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FET
1991-08-14
COLOR VIDEO CAMERA
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FET
1990-10-26
PRECISION OPTICS ENDOSCOPE ADAPTER
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FET
1990-10-19
PRECISION OPTICS IMAGE COUPLER
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FET
1990-10-19
PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)
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FET
1990-05-15
MEDILASE 5010 ENDOSCOPE CONSOLE
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FET
1987-04-17
OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)
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FET
1986-01-21
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
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FET
1984-10-04
VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y
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FET
1983-06-03
CRM-100 COLOR VIDEO CAMERA
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FET
1983-04-18
CRM-114 COLOR VIDEO CAMERA
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FET
1982-10-22
ENDOSCOPIC VIDEOSYSTEM
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FET
1982-04-01
SYN-OPTICS #5200
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FET
1981-03-02
ENDOSCOPIC CLOSED CIRCUIT COLOR TV SYST.
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