Pentax Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its IMAGINA endoscopy system.

The new endoscopy platform has been developed to use in gastrointestinal (GI) procedures at ambulatory surgery centres (ASCs).

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

Pentax Medical has designed the new endoscopy system to meet the requirements of ASC’s and avoid the trade-off between cost and quality care.

The IMAGINA endoscopy system provides images in1080p resolution

The new system, which is provided with a sleek and touch-screen LCD interface on the processor, offers images in1080p resolution. It also helps to avoid the use of expensive periodic bulb replacements through providing better cost predictability.

The IMAGINA system 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.

The IMAGINA i10c series is claimed to be the endoscope platform that includes distally mounted LED lights, HD+ CMOS image sensor and PENTAX i-SCAN features that offer pristine and crystal-clear visualisation for the assessment of the 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.”

Pentax Medical, a business unit of Hoya Group, offers endoscopic imaging devices and solutions to the global medical community.

In November 2019, Pentax Medical introduced an advanced and high-definition DEC HD duodenoscope in the US.