FDA 510(K) For Intrinsic Medical 3D IMI Spectrum Workstation

In short

Intrinsic Medical Imaging  announced it has received FDA pre-market notification clearance for its groundbreaking IMI Spectrum 3D imaging workstation (K121023). The company says its next generation 3D capabilities will provide visualisation and quantification tools designed to overcome errors, inconsistencies and challenges associated with analysing images utilising existing conventional 2D and 3D methods.


Intrinsic Medical Imaging describes itself as a pioneer in trailblazing high performance 3D medical imaging software. It uses uncompressed rendering techniques that preserve the integrity of the data from 2D to 3D while enabling the user to navigate in real-time, anywhere in the volume, while mitigating visual artifacts and creating a more natural and user-friendly environment.

High-performance algorithms process more than 100 times more operations per second than existing 3D solutions, generating a claimed order-of-magnitude improvement in spatial resolution and image detail over existing standards. The IMI Spectrum 3D image visualization platform provides clinicians with diagnostic, planning and treatment solutions to enhance clinical accuracy and speed with the goal of saving lives.

Clinician comments

“Intrinsic provides revolutionary, advanced 3D visualization which could enable a virtual angioscopy of the inside of cardiac structures through a simple, noninvasive CT scan,” said Arie Blitz, MD, director, Heart Transplantation and Mechanical Circulatory Support, University Hospitals Case Medical Center, Cleveland, Ohio. “For example, we processed a patient’s standard 2D CT images using the IMI technology and saw thrombi in 3D previously undetected in 2D. This is amazing technology.”

Company comments

“Receipt of this clearance is a significant step for our company and we look forward to improving patient outcomes while reducing unnecessary healthcare expenditures through the introduction of the IMI Spectrum later this year,” said Jorey Chernett, CEO of Intrinsic Medical Imaging.

“Engaging clinicians throughout the development process is core to our commercialization strategy and clinical feedback has been extremely positive on the potential of the IMI Spectrum technology. Intrinsic has attracted a highly accomplished team with deep domain expertise focused on revolutionizing 3D medical imaging.”

Source: Intrinsic Medical Imaging, PR Web