Gamma camera developer ParkMedical Systems has filed a 510(k) application with the Food andDrug Administration for Isocam 2, the company's dual-head digitalcamera. Park filed the application in February, according to thecompany. Isocam 2 will be the
Gamma camera developer ParkMedical Systems has filed a 510(k) application with the Food andDrug Administration for Isocam 2, the company's dual-head digitalcamera. Park filed the application in February, according to thecompany.
Isocam 2 will be the second in Park's line of digital gammacameras.
Toronto-based Park began deliveries of a single-head versionof Isocam this year. The Isocam systems convert analog signalsto digital within individual photomultiplier tubes (SCAN 2/16/94and 4/7/93).
Isocam 2 will be a double threat to other gamma camera makers.Not only is the system digital, but the detector heads are adjustableto the 90º position for cardiac studies, according to thecompany. Isocam 2 will thus go head-to-head with Genesys Vertexfrom ADAC Laboratories and Sopha Medical's Sophycamera DST inthe adjustable dual-head segment.
In addition to its adjustable dual detectors, Isocam 2 canconduct 90º cardiac studies without moving the patient bedup and down, the company said. The camera's gantry is mountedon rails, allowing the camera to do a whole-body study in onepass.
Park Medical Systems, the principal subsidiary of Park Meditech,recently unified its corporate structure, absorbing several relatednuclear medicine companies and discontinuing the Isis name usedby the company that handled development of the Isocam line.
Park Meditech raised $9 million last month in a private placementoffering of 2.57 million special warrants, exchangeable for oneshare of common stock in the company and half of a common sharepurchase warrant. The cash will help ensure that Park MedicalSystems is adequately funded as the pace of Isocam productionand marketing picks up.
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