Endoscopic Video Imaging System/component, Gastroenterology-urology

Product Code: FET

Gastroenterology/Urology TV Receivers & Products Containing Same

Definition: To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.

Applicable Standards: Television Receivers. [1020.10]

Code of Federal Regulations: 876.1500


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as FET

1794Endoscopic Video Imaging System/component, Gastroenterology-urologyEndoscope And Accessories.

Total Product Life Cycle (TPLC) Devices

1794Endoscopic Video Imaging System/component, Gastroenterology-urologyEndoscope And Accessories.

Pre-market Notifications for FET

K221174Telepack +KARL STORZ Endoscopy America, Inc
K212808Logic Hd Camera Head Green, System GreenRichard Wolf Medical Instruments Corporation
K211332D Camera ControllerRichard Wolf Medical Instruments Corporation
K202646Visera Elite II Video System CenterOlympus Medical Systems Corp.
K201200Visera Elite II Video System CenterOlympus Medical Systems Corp.
K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter For Controller 5525Richard Wolf Medical Instruments Corporation
K193235Telepack +Karl Storz Endoscopy America, Inc.
K192286FUJIFILM EP-6000 Video ProcessorFUJIFILM Corporation
K190648Pusen Eview Medical Video Endoscope Image ProcessorZhuhai Pusen Medical Technology Co., Ltd.
K190449Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera HeadOlympus Medical Systems Corp.
K182696Telepack X LEDKARL STORZ Endoscopy-America, Inc
K180583LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEADRichard Wolf Medical Instruments Corporation
K180414EPX-4440FN Digital Video Processor With Light SourceFUJIFILM New Development U.S.A., Inc.
K1728174K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EAOlympus Medical Systems Corp.
K163675Processor VP-7000, Light Source BL-7000FUJIFILM Medical System U.S.A., Inc.

Global Unique Device Identification Database

20845854038892Endoscopic video imaging system/component, gastroenterology-urology
20845854038885Endoscopic video imaging system/component, gastroenterology-urology
20845854038861Endoscopic video imaging system/component, gastroenterology-urology
20845854024888Endoscopic video imaging system/component, gastroenterology-urology
20845854024871Endoscopic video imaging system/component, gastroenterology-urology
04961333243242Endoscopic Video Imaging System/Component, Gastroenterology-Urology
04961333240180Endoscopic Video Imaging System/Component, Gastroenterology-Urology
04961333232628Endoscopic Video Imaging System/Component, Gastroenterology-Urology
04961333232611Endoscopic Video Imaging System/Component, Gastroenterology-Urology
04961333232581Endoscopic Video Imaging System/Component, Gastroenterology-Urology
04961333228928Endoscopic Video Imaging System/Component, Gastroenterology-Urology
04961333228188Endoscopic video imaging system/component, gastroenterology-urology
04961333225224Endoscopic video imaging system/component, gastroenterology-urology
04961333169061Endoscopic video imaging system/component, gastroenterology-urology
04961333083084Endoscopic video imaging system/component, gastroenterology-urology

Maude Adverse Events

VISERA 4K UHD CAMERA CONTROL UNITOLYMPUS MEDICAL SYSTEMS CORP.2020-03-31
VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2020-03-30
HIGH DEFINITION LCD MONITOROLYMPUS MEDICAL SYSTEMS CORP.2020-03-28
HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2020-03-09
HD AUTOCLAVABLE CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2020-03-03
HIGH DEFINITION LCD MONITOROLYMPUS MEDICAL SYSTEMS CORP.2020-03-03
VISERA ELITE VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2020-02-26
VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2020-02-12
EVIS LUCERA ELITE VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2020-02-12
IMAGE1 S 4U-LINK MODULE FOR IMAGE1 S 4K CAMERA HEADSKARL STORZ SE & CO. KG2020-02-11
VISERA ELITE VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2020-02-07
VISERA ELITE VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2020-02-06
HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2020-02-05
AIDA HD CONNECTKARL STORZ GMBH & CO. KG2020-02-04
VISERA ELITE VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2020-02-04
VISERA ELITE VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2020-02-02
4K CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2020-01-28
EVIS LUCERA ELITE VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2020-01-28
CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2020-01-23
VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-12-16
VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-12-09
ENDOCAMRICHARD WOLF GMBH2019-11-27
EVIS LUCERA VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-11-25
VISERA ELITE VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-11-18
CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2019-11-18
HD CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2019-11-14
EVIS EXERA III VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-11-14
CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2019-11-01
CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2019-10-31
VISERA PRO VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-10-29
SINGLE USE DISTAL COVEROLYMPUS MEDICAL SYSTEMS CORP.2019-10-16
CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2019-10-08
CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2019-10-03
VISERA ELITE VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-09-30
CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2019-09-26
EVIS LUCERA ELITE VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-09-24
HIGH DEFINITION LCD MONITOROLYMPUS MEDICAL SYSTEMS CORP.2019-09-20
GAS/WATER VALVEOLYMPUS MEDICAL SYSTEMS CORP.2019-09-04
GAS/WATER VALVEOLYMPUS MEDICAL SYSTEMS CORP.2019-09-04
HD CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2019-09-04
VISERA PRO VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-08-26
4K CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2019-08-26
VISERA PRO VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-08-20
HD CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2019-08-08
HIGH DEFINITION LCD MONITOROLYMPUS MEDICAL SYSTEMS CORP.2019-07-31
VISERA ELITE VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-07-31
HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2019-07-30
HIGH DEFINITION LCD MONITOROLYMPUS MEDICAL SYSTEMS CORP.2019-07-30
EVIS EXERA III VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-07-24
HD AUTOCLAVABLE CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.2019-07-23

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