Imagina GI endoscope gets 510(k) clearanceMarch 6, 2020
Imagina Endoscopy System, an innovative endoscopy platform for gastrointestinal (GI) procedures at Ambulatory Surgery Centers (ASCs), has been granted US FDA 510(k) clearance, Pentax Medical said.
Imagina offers practitioners a modern user interface and unique endoscope design to provide excellent visualization, improve the operator experience and positively influence long-term patient care costs.
The system features a sleek, touch-screen LCD interface on the processor and displays brilliant images in crisp 1080p resolution, all while providing greater cost predictability by eliminating the need for expensive periodic bulb replacements. It includes Pentax i-Scan, a real-time, digital image enhancement technology that provides the user with an enhanced view of the texture of the mucosal surface and the blood vessels.
Additionally, the Imagina i10c series endoscope platform provides distally mounted LED lights, an HD+ CMOS image sensor, and Pentax i-Scan—features that provide pristine, crystal-clear visualisation for confident assessment of the GI tract.
The i10c series also offers greater ergonomic comfort for the endoscopist, with scopes that are up to 20–25% lighter and a waterproof connector that is 40% lighter, delivering greater convenience to reprocessing staff.