This smallintestine endoscope system produces extremely. Video capsule endoscopy for small bowel examination j gastrointestin liver dis september 2007 vol. The olympus endocapsule takes two pictures per second for approximately twelve hours as it travels through the esophagus, stomach, small intestine, and large. Singleuse aspiration needle nau200h from olympus medical systems. Endocapsule 10 system the endocapsule 10 system is a comprehensive system for fast, efficient, and precise examinations of the small intestine.
Wireless ce is performed using the pillcam given diagnostic imaging system previously called. The accompanying software endocapsule software 10 has red color detection and 3dimensional tracking functions. 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. February 2015 fda 510k clearances fda 510k clearances during february, 2015 summary of 510k clearances. Capture image rate changes from 2 to 6 fps when the system determines the capsule is moving more quickly. List of devices made by the manufacturer olympus medical.
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. Filmarray gastrointestinal panel for use with filmarray 2. Mar, 2015 february 2015 510k clearances 510k summaries or 510k statements for final decisions rendered during the period february 2015. Stateoftheart olympus endoscopic imaging technology delivers highquality images with wide viewing angle to facilitate accurate observations and reliable diagnoses.
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. Olympus launches nextgeneration endocapsule 10 system for. Wireless capsule endoscopy to diagnose disorders of the. Thumbnail data the data which contains thumbnails of the selected images and comments added by a physician. The system features advanced optics and imaging designed to deliver exceptional images of the mucosa. Dmrc light cure orthodontic adhesive system daville materials llc 510k no. For medicare advantage, please refer to the medicare coverage section below for coverage guidance. Endocapsule 10 system endoscopes all products products. View online or download olympus endocapsule instruction manual. 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. Capsule endoscopy is a technology that uses a swallowed video capsule to take photographs of the inside of the esophagus, stomach, and small intestine. Page 18 the process in which a physician imports thumbnail data from a workstation after examination on endo capsule software light.
Optimising the performance and interpretation of small bowel. Single use balloon dilator v with knife from olympus medical systems. A patient fasts for 10 hours prior to the exam, then swallows the pillcam sb with a sip of water. Mar 24, 2015 here are four gastroenterology and endoscopy devices that received fda 510k clearance in february. 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. Endocapsule ec10 sees 10 % more mucosa than other capsule endoscopy platforms with a 160 degree wideangle field of view. After the capsule is activated and swallowed with a glass of water by the patient, it begins transmitting images of the digestive system to a. 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. Fda clears 27 gi devices in 2015 thus far beckers asc.
Ecs10 low power transmitter user manual olympus medical. 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. Physio fitness physio rehab tim keeley recommended. Here are four gastroenterology and endoscopy devices that received fda 510k clearance in february.
Fda clears 4 giendoscopy devices in february the musc digest. Endocapsule 10 system reflects our vast experience in optodigital technology for endoscopes. It is equipped with a light source, batteries, a radio transmitter and antenna. Endocapsule software 10 light from olympus medical systems. 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. Examinations are further supported by the systems advanced software. Endocapsule recorder set maj 2029 the size of a vitamin, the capsule endoscope consists of a light source, camera, transmitter, and batteries. Jul 12, 2016 the endocapsule 10 system is a comprehensive system for fast, efficient, and precise examinations of the small intestine. Fda releases february 2015 510k clearances massdevice. The endocapsule software 10 upgrade package maj2190. For added convenience, endocapsule software 10 light gives you the ability to continue postexamination procedures even without direct access to the hospital network. Accessgudid endocapsule software 10 light 04953170373800 no description. Endocapsule from olympus is a small bowel endoscopy system that uses a camera within a capsule that is swallowed by the patient.
Endocapsule ec10 features intelligent reading modes that help you manage your capsule practice, and your time, more efficiently. Stateoftheart olympus endoscopic imaging technology delivers highquality images with wide viewing angle to facilitate accurate observations and. Power lamp 36 olympus capsule endoscope system system. The olympus endocapsule system brings you 65 years of gi endoscopy innovation, all in one powerful little capsule. The olympus endocapsule software provides a complex. 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. In addition, the endocapsule features automatic brightness adjustment capabilities similar to that used in olympus endoscopes and has a battery life of 12 h. Be familiar with the endo capsule hardware and software. Video capsule endoscopy for small bowel examination. Fda clears 4 giendoscopy devices in february the musc. As the capsule travels through the small intestine, pictures are transmitted to a light weight recorder that is worn around your waist. The medical device maj2189 ec 10 endocapsule software light vers. Medical policy wireless capsule endoscopy to diagnose. Endocapsule recorder set maj2029 endocapsule maj2027 lead antenna unit.
Olympus capsule endoscopy animation olympus endocapsule. Medical device maj2188 ec10 endocapsule software vers. Change playback speed depending on differences in images. Fda 510k applications submitted by 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. Immulite igf control module, immulite gastrin control module from siemens healthcare diagnostics.
Page 1 of ecs10 low power transmitter user manual olympus medical systems. February 2015 510k clearances 510k summaries or 510k statements for final decisions rendered during the period february 2015. 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. Capsule endoscopy animation olympus endocapsule youtube.
Intended for visualization of the small bowel mucosa. Total 510ks this period 208 total with summaries 193 total. Fda 510k applications submitted by olympus medical. The endocapsule 10 system features software that allows secure case reading outside the hospital environment. 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 endocapsule 10 system is a comprehensive system for fast, efficient, and precise. 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. Components endocapsule 10 v2 software light maj2189. Endocapsule software 10 light means that you can create reports when and where it suits you, without compromising on data security. Olympus documentation system is not available in some regions. 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 pillcam sb 3 system optimizes tissue coverage with the most advanced capsule endoscopy technology. Seamless endobase integration makes reporting even faster. Olympus capsule endoscopy for small bowel examination.
When 10 gastroenterology trainees with experience in flexible endoscopy. Capsule endoscopy endocapsule 10 system olympus medical. 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.
The endocapsule 10 system reflects our vast experience in optodigital technology for. Olympus endocapsule instruction manual pdf download. 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. Coverage is subject to members specific benefits, group specific policy will supersede this policy when applicable. The capsule is approximately the size of a vitamin. Wireless capsule endoscopy to diagnose disorders of the small bowel, esophagus, and colon. Olympus endocapsule 10 system, a camera pill for improved. Whether youre an olympus camera owner or are considering making the switch, discover tips, events, and more to help guide your photographic journey. Secure network data storage procedure data can be easily shared with satellite workstations attached to the hospital network.