Digirad (Poway, CA) received clearance from the FDA for expanded indications for the company’s ergo imaging system. These include lymphatic scintigraphy and parathyroid scintigraphy, for help assessing lesions in the breast and other small parts of the body. Initial clearance by the FDA came three years ago.
The system features a 12.25 x 15.5 inch field of view, an intrinsic spatial resolution of 3.25 mm, an energy resolution of 7.9%, and 5 Mcps.
The clearance includes indications for lymphatic scintigraphy and parathyroid scintigraphy, both nuclear diagnostic imaging tests, and to aid in the evaluation of lesions in the breast and other small body parts. The ergo™ can also be used intra-operatively when protected by sterile drapes. When used for breast imaging, the ergo™ System is indicated to serve as an adjunct to mammography or other primary breast imaging modalities.
The ergo™ Imaging System provides powerful new solid-state technology substantially raising overall performance capabilities and significantly lowering total lifecycle costs. The Large Field of View (LFOV) camera (12.25″ x 15.5″) provides ideal utility for a wide range of procedures performed in nuclear medicine or throughout the hospital. The sleek, open gantry/detector design is patient friendly and convenient to image patients sitting up and lying on stretchers or beds. Its lightweight, portable design makes it possible to use in nearly any room or department.
The portable design of the ergo™ Imaging System offers the potential to increase return on investment, reduce operational costs, and increase study volume over traditional fixed assets.
Flashback: Ergo Portable Nuclear Imaging System Receives 510(k) Clearance
Product page: The ergo…
Press release: Digirad Corporation Receives U.S. FDA 510(k) Market Clearance for Expanded Uses of ergo(TM) Imaging System
