Pentax Medical gets FDA approval for IMAGINA endoscopy system

16 January 2020 (Last Updated January 16th, 2020 12:12)

Pentax Medical, a unit of Hoya Group, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its IMAGINA endoscopy system.

Pentax Medical gets FDA approval for IMAGINA endoscopy system
PENTAX Medical’s IMAGINA endoscopy system. Credit: PRNewsfoto / PENTAX Medical.

Pentax Medical, a unit of Hoya Group, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its IMAGINA endoscopy system.

The endoscopy platform was developed for gastrointestinal (GI) procedures at ambulatory surgery centres (ASC).

IMAGINA’s user interface and endoscope design features will provide practitioners with enhanced visualisation and improved operator experience.

Pentax Medical designed the system to meet ACS requirements and avoid the trade-off between cost and quality care.

IMAGINA system comprises a sleek and touch-screen LCD interface on the processor and offers images in 1080p resolution. It also helps to avoid the use of expensive periodic bulb replacements, providing better cost predictability.

The system also features Pentax i-SCAN real-time and digital image enhancement technology, which offers an improved view of the texture of the mucosal surface and the blood vessels to the user.

Furthermore, the IMAGINA i10c series is the only endoscope platform that offers distally mounted LED lights, HD+ CMOS image sensor and PENTAX i-SCAN, allowing clear visualisation to assess GI tract.

Pentax Medical Americas president and CEO David Woods said: The launch of the IMAGINA allows us to best serve the needs of the core GI market and our system provides maximum cost predictability without compromising on the standard of care delivered to patients.

“IMAGINA eliminates the costliest components of a premium GI endoscopy system and still adheres to the highest imaging standards in the industry: a true testament to our commitment to better patient outcomes, improved patient experience and a lower overall cost of care.”

In November, the FDA gave marketing approval for the Pentax Medical Video Duodenoscope ED34-i10T2, the first duodenoscope with a sterile, disposable elevator component.