Optimising the performance and interpretation of small bowel. Filmarray gastrointestinal panel for use with filmarray 2. Capsule endoscopy is a technology that uses a swallowed video capsule to take photographs of the inside of the esophagus, stomach, and small intestine. Change playback speed depending on differences in images. Singleuse aspiration needle nau200h from olympus medical systems. Secure onthego reporting endocapsule software 10 light means that you can create reports when and where it suits you, without compromising on data security.
Identical images, and images full of bubbles and debris, are superimposed and speeds are optimized to move more quickly past images recorded when the capsule is motionless to vastly reduce playback times, increasing reading efficiency and effectiveness. The accompanying software endocapsule software 10 has red color detection and 3dimensional tracking functions. The medical device maj2189 ec 10 endocapsule software light vers. Power lamp 36 olympus capsule endoscope system system. February 2015 fda 510k clearances fda 510k clearances during february, 2015 summary of 510k clearances. The olympus endocapsule software provides a complex. Senior executive managing officer akihiro taguchi will start sales in early february 20 of its endocapsule 10 system, a small intestinal capsule endoscope for observation with higher image quality. The pillcam sb 3 system optimizes tissue coverage with the most advanced capsule endoscopy technology. Fda clears 4 giendoscopy devices in february the musc. View online or download olympus endocapsule instruction manual. Single use balloon dilator v with knife from olympus medical systems. Jul 16, 2016 capsule endoscopy is a technology that uses a swallowed video capsule to take photographs of the inside of the esophagus, stomach, and small intestine.
List of devices made by the manufacturer olympus medical. One case series by culliford et al 2005 evaluated 47 patients with complicated celiac disease and found unexpected additional findings in 60% of patients, most of which were ulcerations. Endocapsule software 10 light means that you can create reports when and where it suits you, without compromising on data security. The capsule is approximately the size of a vitamin. Endocapsule recorder set maj 2029 the size of a vitamin, the capsule endoscope consists of a light source, camera, transmitter, and batteries. Medical device maj2188 ec10 endocapsule software vers.
Dmrc light cure orthodontic adhesive system daville materials llc 510k no. Wireless ce is performed using the pillcam given diagnostic imaging system previously called. Components endocapsule 10 v2 software light maj2189. Endocapsule recorder set maj2029 endocapsule maj2027 lead antenna unit. In addition, the endocapsule features automatic brightness adjustment capabilities similar to that used in olympus endoscopes and has a battery life of 12 h. The system features advanced optics and imaging designed to deliver exceptional images of the mucosa. It is equipped with a light source, batteries, a radio transmitter and antenna. Single use preloaded sphincterotome from olympus medical systems. Designed to optimize your small bowel capsule endoscopy practice, the featurerich and highly intuitive endocapsule 10 platform is the culmination of peerless olympus imaging technology, continuous software innovation, thoughtful advances in procedural and practice efficiency, and a comprehensive approach to. The endocapsule 10 system is a comprehensive system for fast, efficient, and precise examinations of the small intestine. Endocapsule software 10 light from olympus medical systems.
Endocapsule ec10 sees 10 % more mucosa than other capsule endoscopy platforms with a 160 degree wideangle field of view. The pillcam sb 3 system allows for direct visualization of the small bowel, supporting greater confidence when monitoring lesions 3 that may be related to crohns disease, obscure bleeding, or iron deficiency anemia. Be familiar with the endo capsule hardware and software. Video capsule endoscopy vce that was launched 10 years ago has become a firstline procedure for examining the small bowel, especially in the case of obscure gastrointestinal bleeding. Total 510ks this period 208 total with summaries 193 total. The 3d track feature unique to ec10 provides a map of the capsules anatomical location within the small bowel which directly correlates to clinical images, thus providing actionable information. A patient fasts for 10 hours prior to the exam, then swallows the pillcam sb with a sip of water. Whether youre an olympus camera owner or are considering making the switch, discover tips, events, and more to help guide your photographic journey. Video capsule endoscopy for small bowel examination. Fda 510k applications submitted by olympus medical. Video capsule endoscopy for small bowel examination j gastrointestin liver dis september 2007 vol.
Wireless capsule endoscopy to diagnose disorders of the small bowel, esophagus, and colon. This smallintestine endoscope system produces extremely. Jul 12, 2016 the endocapsule 10 system is a comprehensive system for fast, efficient, and precise examinations of the small intestine. Secure network data storage procedure data can be easily shared with satellite workstations attached to the hospital network.
Examinations are further supported by the systems advanced software. Ecs10 low power transmitter user manual olympus medical. Fda releases february 2015 510k clearances massdevice. Olympus capsule endoscopy for small bowel examination. Olympus endocapsule instruction manual pdf download. Endocapsule 10 system reflects our vast experience in optodigital technology for endoscopes. Medical policy wireless capsule endoscopy to diagnose. Coverage is subject to members specific benefits, group specific policy will supersede this policy when applicable. Endocapsule 10 system endoscopes all products products. For capsule endoscopy, the intestines are first cleared of residual food and bacterial debris with the use of laxatives andor purges very similar to the laxatives and purges used before. Endocapsule 10 system the endocapsule 10 system is a comprehensive system for fast, efficient, and precise examinations of the small intestine. Designed to optimize your small bowel capsule endoscopy practice, the featurerich and highly intuitive endocapsule 10 platform is the culmination of peerless olympus imaging technology, continuous software innovation, thoughtful advances in procedural and practice efficiency, and a comprehensive approach to service and support. Olympus endocapsule 10 system, a camera pill for improved visualization of small intestine may th, 2014 medgadget editors gi olympus is releasing its new endocapsule 10 system, a swallowable.
Immulite igf control module, immulite gastrin control module from siemens healthcare diagnostics. Endocapsule ec10 features intelligent reading modes that help you manage your capsule practice, and your time, more efficiently. The endocapsule 10 system features software that allows secure case reading outside the hospital environment. Olympus endocapsule 10 system, a camera pill for improved. Accessgudid endocapsule software 10 light 04953170373800 no description. Capsule endoscopy endocapsule 10 system olympus medical. The olympus endocapsule takes two pictures per second for approximately twelve hours as it travels through the esophagus, stomach, small intestine, and large. Reporting design exactly matched to your needs the reporting of findings is fast and intuitive thanks to customized report design templates. Bcbsnj medical policy for radiology policy number 017. Seamless endobase integration makes reporting even faster. Capture image rate changes from 2 to 6 fps when the system determines the capsule is moving more quickly. For medicare advantage, please refer to the medicare coverage section below for coverage guidance. Intended for visualization of the small bowel mucosa. May 05, 2014 outstanding visualization the endocapsule 10 system features advanced olympus lens technology and sensitive, highresolution image sensor technology to provide clear and vivid imaging results for.
When 10 gastroenterology trainees with experience in flexible endoscopy. Olympus capsule endoscopy animation olympus endocapsule. The olympus endocapsule system brings you 65 years of gi endoscopy innovation, all in one powerful little capsule. As the capsule travels through the small intestine, pictures are transmitted to a light weight recorder that is worn around your waist. For added convenience, endocapsule software 10 light gives you the ability to continue postexamination procedures even without direct access to the hospital network. Stateoftheart olympus endoscopic imaging technology delivers highquality images with wide viewing angle to facilitate accurate observations and. Endocapsule from olympus is a small bowel endoscopy system that uses a camera within a capsule that is swallowed by the patient. The endocapsule 10 system is a comprehensive system for fast, efficient, and precise. Fda 510k applications submitted by olympus medical systems. Physio fitness physio rehab tim keeley recommended. Olympus launches nextgeneration endocapsule 10 system for. Endocapsule software 10 light for added convenience, endocapsule software 10 light gives you the ability to continue postexamination procedures even without direct access to the hospital network. The endocapsule software 10 upgrade package maj2190.
Page 1 of ecs10 low power transmitter user manual olympus medical systems. Olympus documentation system is not available in some regions. Stateoftheart olympus endoscopic imaging technology delivers highquality images with wide viewing angle to facilitate accurate observations and reliable diagnoses. Olympus endocapsule 10 system, a camera pill for improved visualization of small intestine may th, 2014 medgadget editors gi olympus is releasing its new endocapsule 10. The equivalent endocapsule software has been evaluated in a single study. February 2015 510k clearances 510k summaries or 510k statements for final decisions rendered during the period february 2015. Endo capsule software light average color bar red color bar endocapsule software light simplified application software for diagnosis in the office environment olympus offers endo capsule software light on a cdr for physicians seeking efficient observation of capsule endoscope examination results on pcs outside the examination room. Thumbnail data the data which contains thumbnails of the selected images and comments added by a physician. Mar 24, 2015 here are four gastroenterology and endoscopy devices that received fda 510k clearance in february. Wireless capsule endoscopy to diagnose disorders of the. Capsule endoscopy animation olympus endocapsule youtube.
Fda clears 27 gi devices in 2015 thus far beckers asc. The endocapsule 10 system reflects our vast experience in optodigital technology for. Here are four gastroenterology and endoscopy devices that received fda 510k clearance in february. Medical device maj2189 ec10 endocapsule software light vers. Jul 06, 2015 shoulder impingement, pain and injury rehabilitation seminar feat. Page 18 the process in which a physician imports thumbnail data from a workstation after examination on endo capsule software light. Mar, 2015 february 2015 510k clearances 510k summaries or 510k statements for final decisions rendered during the period february 2015. Fda clears 4 giendoscopy devices in february the musc digest.
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