Atlas FDA

FET

100 FDA 510(k) clearances · Product code

84 daysmedian time to decision
244 days90th percentile
100clearances measured

FDA profile

Official device name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Adverse events (MAUDE)
2021: 5,300 · 2022: 6,156 · 2023: 8,199 · 2024: 13,153 · 2025: 14,682 · 2026: 10,603
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 (K261880)Fujifilm Corporation2026-07-02
HD Camera Head OLYMPUS CH-S200-08-LB (K261260)Olympus Medical Systems Corporation2026-06-24
ProVee Video Processing Unit (PV-003) (K251734)Proverum Limited2025-09-24
UL UHD-Clear View 4K Camera System (UL-3Chip 4K) (K250462)Univlabs Technologies Private Limited2025-08-11
Endoscopic Camera System (K250204)Shenzhen Sophway Technology Co., Ltd.2025-07-01
FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (K243260)Fujifilm Corporation2025-04-11
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 (K242067)Olympus Corporations of the Americas2025-04-02
Endoscopic Video Image Processor (RP-IPD-V1000F) (K243321)Guangzhou Red Pine Medical Instrument Co., Ltd.2025-02-07
Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (K241532)Shanghai SeeGen Photoelectric Technology Co., Ltd.2024-10-22
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (K241371)Olympus Medical Systems Corporation2024-07-03
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 (K222584)Olympus Medical Systems Corporation2023-04-26
Logic Hd camera head green, System green (K212808)Richard Wolf Medical Instruments Corporation2022-06-14
Telepack + (K221174)Karl Storz Endoscopy America, Inc.2022-05-13
D Camera Controller (K211332)Richard Wolf Medical Instruments Corporation2021-10-01
Visera Elite II Video System Center (K202646)Olympus Medical Systems Corp.2020-10-29
Image1 S CCU, Image1 S 4U Camera Head (K201135)KARL STORZ Endoscopy-America, Inc.2020-09-01
Visera Elite II Video System Center (K201200)Olympus Medical Systems Corp.2020-07-22
Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 (K200617)Richard Wolf Medical Instruments Corporation2020-06-23
FUJIFILM EP-6000 Video Processor (K192286)Fujifilm Corporation2020-05-01
Telepack + (K193235)Karl Storz Endoscopy America, Inc.2019-12-20
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head (K190449)Olympus Medical Systems Corp.2019-08-30
Pusen Eview Medical Video Endoscope Image Processor (K190648)Zhuhai Pusen Medical Technology Co., Ltd.2019-03-29
Telepack X LED (K182696)KARL STORZ Endoscopy-America, Inc.2018-11-20
LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD (K180583)Richard Wolf Medical Instruments Corporation2018-06-28
EPX-4440FN Digital Video Processor with Light Source (K180414)Fujifilm New Development U.S.A., Inc.2018-05-24
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA (K172817)Olympus Medical Systems Corp.2017-10-17
Processor VP-7000, Light Source BL-7000 (K163675)Fujifilm Medical System U.S.A., Inc.2017-04-25
ENDOCAM Flex HD Camera System 5521 (K161204)Richard Wolf Medical Instruments Corporation2017-01-11
Image1 SPIES System (K160044)Karl Storz Endoscopy America, Inc.2016-02-01
HD-Camera HDC1000 (K152109)W.O.M. World of Medicine GmbH2015-10-13
EPX-4440HD and EPX-4400HD with FICE (K150221)Fujifilm Medical System U.S.A., Inc.2015-10-01
IMAGE1 SPIES (K131953)KARL STORZ Endoscopy-America, Inc.2013-12-20
THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 (K130423)Richard Wolf Medical Instruments Corp.2013-04-03
PENTAX EPK-I5020 VIDEO PROCESSOR (K113873)Pentax of America, Inc.2012-06-22
IMAGE1 GI CCU MODEL 22203020-114 (K111997)KARL STORZ Endoscopy-America, Inc.2012-04-06
COLONOSCOPY ASSISTANT (K102949)Sti Medical Systems, LLC2011-06-15
FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR (K102466)Fujinon, Inc.2011-05-25
AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 (K102059)Olympus Medical Systems Corporation2010-10-08
VS-100 ILLUMINATION AND IMAGING SYSTEM (K090800)Schoelly Imaging, Inc.2009-05-18
HD CAMERA HEAD OTV-S7PROH-HD-L08E (K083155)Olympus Medical Systems Corporation2009-01-13
IEC MEDSIGHT AND MEDBRIGHT (K080809)Innovative Endoscopy Components, LLC2008-08-11
ENDOSCOPY VIDEO CAMERA SYSTEM (K081585)Vision Systems Group, A Division of Viking Systems2008-06-20
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL (K070716)KARL STORZ Endoscopy-America, Inc.2007-05-31
AIDA WITH DICOM AND HL7 INTERFACE (K043324)KARL STORZ Endoscopy-America, Inc.2005-04-04
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 (K041494)Olympus Corporation2004-07-01
KSEA OPSERVER LAP (K031895)KARL STORZ Endoscopy-America, Inc.2003-09-23
VP-1000; MED CAM 100; VP-3000A; MED CAM 300 (K032544)Mgb Endoskopische Gerate GmbH (Berlin)2003-09-02
ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250 (K032545)Mgb Endoskopische Gerate GmbH (Berlin)2003-09-02
1-CCD ENDOCAM 5520 SYSTEM (K023659)Richard Wolf Medical Instruments Corp.2003-01-29
MODIFICATION TO VISTA STEREOSCOPE SYSTEM (K020301)Vista Medical Technologies, Inc.2002-02-12
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES (K012660)Gimmi GmbH2001-12-20
HILL-ROM PRIMAVIEW MONITOR SYSTEM (K013709)Hill-Rom, Inc.2001-11-16
KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM (K003325)Karl Storz Imaging, Inc.2001-04-27
KSEA SCB-RUI SCO (K003113)KARL STORZ Endoscopy-America, Inc.2001-03-27
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905 (K003710)Smith & Nephew, Inc.2001-02-02
KSEA SCB-RUI (K994348)KARL STORZ Endoscopy-America, Inc.2000-03-03
KARL STORZ AUTOCLAVABLE CAMERA HEAD (K994090)Karl Storz Imaging, Inc.2000-02-04
KSEA SCBCOM (K992469)Karl Storz Endoscopy1999-10-15
FLEXISCOPE IQ 101 (K992362)Schoelly Fiberoptic GmbH1999-08-05
MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) (K981856)Greatbatch Scientific1998-07-29
VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM (K981827)Angiolaz, Inc.1998-07-28
S-357 VIDEO IMAGING SYSTEM (K973798)Sopro1997-12-03
KARL STORZ DIRECT COUPLED CAMERA HEAD (K973252)Karl Storz Imaging, Inc.1997-11-24
S-357 VIDEO IMAGING SYSTEM (K972540)Sopro1997-09-18
OLYMPUS OES OTV-S5C VIDEO SYSTEM (K971416)Olympus America, Inc.1997-07-16
VISTA SINGLE CHIP VIDEO CAMERA (K971373)Vista Medical Technologies, Inc.1997-05-20
C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ (K964173)Richard Wolf Medical Instruments Corp.1996-12-13
S-57 VIDEO IMAGING SYSTEM (K962024)Del Medical Systems Corp.1996-07-09
EVIS 140 SYSTEM (K954451)Olympus America, Inc.1996-03-29
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION) (K954734)The Tulip Mfg. Co.1995-11-14
KSEA REVERSE VIDEO (K952482)KARL STORZ Endoscopy-America, Inc.1995-10-23
EPX-310 VIDEO PROCESSOR (ENDOSCOPY) (K950417)Marks & Murase1995-07-21
KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS (K950975)Karl Storz Imaging, Inc.1995-05-11
KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS (K950974)Karl Storz Imaging, Inc.1995-05-11
SERIES 400 GASTROENTEROLOGY SYSTEM (K944620)Marks & Murase1995-04-27
200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM (K944759)Fujinon, Inc.1995-04-11
OKTAS STEREO VIEWING SYSTEM (K944254)Oktas1994-11-30
OLYMPUS SWITCHING UNIT MODEL SU-1 (K944081)Olympus America, Inc.1994-11-14
KARL STORZ ENDOVISION UROCAM/HYSTEROCAM (K940283)Medical Concepts, Inc.1994-09-28
OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM (K941919)Oktas1994-06-17
EIDOLON ENDOSCOPE COUPLER (K942141)Eidolon Corp.1994-05-27
FUJINON VIDEO LAPAROSCOPE -- MODIFIED (K932312)Fujinon, Inc.1994-02-16
EPM-3300 VIDEO PROCESSOR (K934918)Pentax Precision Instrument Corp.1994-02-07
ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA (K934623)Endomedix1993-12-02
NOBLES-LAI IMAGING SYSTEM (K920026)Nobles-Lai Engineering, Inc.1992-07-28
SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 (K912447)Medical Laser, Inc.1991-09-27
IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS (K912531)Innovative Medical Devices, Inc.1991-09-04
COLOR VIDEO CAMERA (K911485)United States Endoscopy Group, Inc.1991-08-14
PRECISION OPTICS ENDOSCOPE ADAPTER (K903459)Precise Optics1990-10-26
PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) (K903457)Precise Optics1990-10-19
PRECISION OPTICS IMAGE COUPLER (K903458)Precise Optics1990-10-19
MEDILASE 5010 ENDOSCOPE CONSOLE (K900380)Medical Laser, Inc.1990-05-15
OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM) (K870680)Medline Industries, Inc.1987-04-17
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS (K853585)Olympus Corp.1986-01-21
VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y (K843198)Life-Tech Intl., Inc.1984-10-04
CRM-100 COLOR VIDEO CAMERA (K831412)Umi, Inc.1983-06-03
CRM-114 COLOR VIDEO CAMERA (K830924)Umi, Inc.1983-04-18
ENDOSCOPIC VIDEOSYSTEM (K822959)Eder Instrument Co, Inc.1982-10-22
SYN-OPTICS #5200 (K820624)Syn-Optics1982-04-01
ENDOSCOPIC CLOSED CIRCUIT COLOR TV SYST. (K810393)Keymed, Inc.1981-03-02

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