PENTAX Medical obtained US FDA 510(k) clearance for new models of the PENTAX Medical i20c Video Endoscope Series

MONTVALE,N.J.,Dec. 10,2024 -- PENTAX Medical,a division of HOYA Group,has obtained US FDA 510(k) clearance for new models of the PENTAX Medical i20c Video Endoscope Series—PENTAX Medical Video Colonoscope EC34-i20cL,PENTAX Medical Video Upper GI Scope EG27‑i20c and Right/Left Wheel ExtenderOE-B17.

The PENTAX Medical i20c Video Endoscope Series,now including slim models EC34-i20cL and EG27-i20c in the United States.

Right/Left Wheel Extender for i20c Video Endoscope Series,model OE-B17.

In combination with thePENTAX Medical INSPIRA™ Video Processor EPK-i8020c,the PENTAX Medical i20c Video Endoscope Series aims to support healthcare professionals in detection,diagnosis and therapy. Physicians can instantly benefit from unparalleled endoscope ergonomics,advanced imaging,and enhanced maneuverability.

The new slim models include the signature features of the i20c endoscope generation: advanced imaging,enhanced maneuverability with adjustable stiffness,and superior ergonomics through the new ErgoFeel control body and EasyOn connector to improve the experiences of the medical professionals who spend countless hours working with the platform. These design improvements have the potential to improve the quality of procedures and optimize the clinical workflow.

In addition to the two new endoscope models,PENTAX Medical also received clearance for their add-on Right/Left Wheel Extender,model OE-B17. This reusable piece is attached to the outer right/left wheel of the endoscope to improve accessibility of the outer wheel for endoscopists with smaller hands.

David Harrison,President,PENTAX Medical Americas comments; "We are thrilled to deliver the slim additions to our well-received i20c endoscope series. We know that US physicians have appreciated the ergonomic control body design changes we have made in the i20c series,and they have been anxiously awaiting these advancements in their slim scopes as well. With the new EC34-i20cL and EG27-i20c,this complete portfolio is poised to deliver better ergonomics,maneuverability,and imaging to all endoscopists without exception."

The PENTAX Medical i20c Video Endoscope Series will be on display at the New York Society for Gastrointestinal Endoscopy (NSYGE) Annual Meeting,December 12-13,and will include the slim i20c innovations for the first time in the United States in PENTAX Medical Booth #302. For more information and to trial the i20c Video Endoscope Series,please contact the local PENTAX Medical Territory Manager or visit: www.pentaxmedical.com/us

About PENTAX Medical

PENTAX Medical is a division of HOYA Group. The company's mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY,CLINICALLY RELEVANT INNOVATION,and SIMPLICITY. PENTAX Medical strives to align with the healthcare community's Triple Aim goals through transparent partnerships with its customers and by providing the highest quality solutions to help them reach their goals,including enabling customers to improve patient outcomes by offering evidence-based solutions across the continuum of care; ensuring value by supporting the customers to improve their efficiency and minimize their healthcare costs; and enriching patient and provider's experience by empowering every member of the care team to achieve optimal outcomes through products,education,and support. Focused on the outcome instead of technological features,PENTAX Medical listens to the healthcare community and their patients,understands their daily obstacles and helps improve endoscopy with smart innovations.

For more information:https://www.pentaxmedical.com

About HOYA

Founded in 1941 in Tokyo,Japan,HOYA Corporation is a global technology and med‑tech company and a leading supplier of innovative high‑tech and medical products. HOYA is active in the fields of lifecare and information technology,providing eyeglasses,medical endoscopes,intraocular lenses,optical lenses,as well as key components for semiconductor devices,LCD panels,and hard disk drives. With over 150 offices and subsidiaries worldwide,HOYA currently employs a multinational workforce of 36,000 people. For more information,please visit: https://www.hoya.com/en/