Endocapsule software 10 light

This smallintestine endoscope system produces extremely. As the capsule travels through the small intestine, pictures are transmitted to a light weight recorder that is worn around your waist. Olympus launches nextgeneration endocapsule 10 system for. February 2015 510k clearances 510k summaries or 510k statements for final decisions rendered during the period february 2015.

Wireless ce is performed using the pillcam given diagnostic imaging system previously called. The equivalent endocapsule software has been evaluated in a single study. Filmarray gastrointestinal panel for use with filmarray 2. Total 510ks this period 208 total with summaries 193 total. Capsule endoscopy is a technology that uses a swallowed video capsule to take photographs of the inside of the esophagus, stomach, and small intestine. 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. 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. Optimising the performance and interpretation of small bowel. Mar 24, 2015 here are four gastroenterology and endoscopy devices that received fda 510k clearance in february.

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 endocapsule 10 system, a camera pill for improved. The accompanying software endocapsule software 10 has red color detection and 3dimensional tracking functions. The olympus endocapsule software provides a complex. Accessgudid endocapsule software 10 light 04953170373800 no description. Mar, 2015 february 2015 510k clearances 510k summaries or 510k statements for final decisions rendered during the period february 2015. Medical device maj2189 ec10 endocapsule software light vers. 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 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. The pillcam sb 3 system optimizes tissue coverage with the most advanced capsule endoscopy technology. 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. Endocapsule recorder set maj2029 endocapsule maj2027 lead antenna unit. The olympus endocapsule takes two pictures per second for approximately twelve hours as it travels through the esophagus, stomach, small intestine, and large. Jul 06, 2015 shoulder impingement, pain and injury rehabilitation seminar feat. Ecs10 low power transmitter user manual olympus medical. Thumbnail data the data which contains thumbnails of the selected images and comments added by a physician.

Fda clears 4 giendoscopy devices in february the musc digest. Olympus capsule endoscopy for small bowel examination. Stateoftheart olympus endoscopic imaging technology delivers highquality images with wide viewing angle to facilitate accurate observations and reliable diagnoses. Capsule endoscopy endocapsule 10 system olympus medical. The capsule is approximately the size of a vitamin. Wireless capsule endoscopy to diagnose disorders of the. The endocapsule 10 system is a comprehensive system for fast, efficient, and precise examinations of the small intestine. Fda clears 27 gi devices in 2015 thus far beckers asc. Fda 510k applications submitted by olympus medical systems. Fda releases february 2015 510k clearances massdevice. The endocapsule 10 system reflects our vast experience in optodigital technology for. Endocapsule recorder set maj 2029 the size of a vitamin, the capsule endoscope consists of a light source, camera, transmitter, and batteries. Secure onthego reporting endocapsule software 10 light means that you can create reports when and where it suits you, without compromising on data security. 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.

Fda clears 4 giendoscopy devices in february the musc. Secure network data storage procedure data can be easily shared with satellite workstations attached to the hospital network. February 2015 fda 510k clearances fda 510k clearances during february, 2015 summary of 510k clearances. 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 instruction manual pdf download. A patient fasts for 10 hours prior to the exam, then swallows the pillcam sb with a sip of water. Fda 510k applications submitted by olympus medical. The endocapsule software 10 upgrade package maj2190. View online or download olympus endocapsule instruction manual. Video capsule endoscopy for small bowel examination. Olympus documentation system is not available in some regions. For medicare advantage, please refer to the medicare coverage section below for coverage guidance.

Intended for visualization of the small bowel mucosa. For added convenience, endocapsule software 10 light gives you the ability to continue postexamination procedures even without direct access to the hospital network. The olympus endocapsule system brings you 65 years of gi endoscopy innovation, all in one powerful little capsule. The system features advanced optics and imaging designed to deliver exceptional images of the mucosa. Page 18 the process in which a physician imports thumbnail data from a workstation after examination on endo capsule software light. It is equipped with a light source, batteries, a radio transmitter and antenna. 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.

When 10 gastroenterology trainees with experience in flexible endoscopy. 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. Bcbsnj medical policy for radiology policy number 017. Capture image rate changes from 2 to 6 fps when the system determines the capsule is moving more quickly.

Page 1 of ecs10 low power transmitter user manual olympus medical systems. The medical device maj2189 ec 10 endocapsule software light vers. Endocapsule 10 system endoscopes all products products. Capsule endoscopy animation olympus endocapsule youtube. Stateoftheart olympus endoscopic imaging technology delivers highquality images with wide viewing angle to facilitate accurate observations and. Physio fitness physio rehab tim keeley recommended. 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. 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. Be familiar with the endo capsule hardware and software. Endocapsule software 10 light means that you can create reports when and where it suits you, without compromising on data security. Olympus capsule endoscopy animation olympus endocapsule. Medical device maj2188 ec10 endocapsule software vers. Single use balloon dilator v with knife from olympus medical systems.

Wireless capsule endoscopy to diagnose disorders of the small bowel, esophagus, and colon. In addition, the endocapsule features automatic brightness adjustment capabilities similar to that used in olympus endoscopes and has a battery life of 12 h. Jul 12, 2016 the endocapsule 10 system is a comprehensive system for fast, efficient, and precise examinations of the small intestine. Video capsule endoscopy for small bowel examination j gastrointestin liver dis september 2007 vol. Endocapsule 10 system reflects our vast experience in optodigital technology for endoscopes. Medical policy wireless capsule endoscopy to diagnose. Change playback speed depending on differences in images. Immulite igf control module, immulite gastrin control module from siemens healthcare diagnostics. Components endocapsule 10 v2 software light maj2189. Whether youre an olympus camera owner or are considering making the switch, discover tips, events, and more to help guide your photographic journey.

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. 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. Here are four gastroenterology and endoscopy devices that received fda 510k clearance in february. 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. Endocapsule from olympus is a small bowel endoscopy system that uses a camera within a capsule that is swallowed by the patient. Endocapsule 10 system the endocapsule 10 system is a comprehensive system for fast, efficient, and precise examinations of the small intestine. Endocapsule ec10 features intelligent reading modes that help you manage your capsule practice, and your time, more efficiently. Single use preloaded sphincterotome from olympus medical systems. The endocapsule 10 system is a comprehensive system for fast, efficient, and precise. List of devices made by the manufacturer olympus medical.

Dmrc light cure orthodontic adhesive system daville materials llc 510k no. Power lamp 36 olympus capsule endoscope system system. Reporting design exactly matched to your needs the reporting of findings is fast and intuitive thanks to customized report design templates. The endocapsule 10 system features software that allows secure case reading outside the hospital environment. Singleuse aspiration needle nau200h from olympus medical systems.