FDA clears Hitachi gamma cameras

The Food and Drug Administration has cleared three Hitachi gammacameras that are the centerpiece of the vendor's planned comebackin nuclear medicine. Two of the cameras are systems manufacturedby Hitachi and formerly marketed by Summit Nuclear, while anotheris a new variable-angle digital dual-head product Hitachi hasdeveloped (SCAN 10/11/94).

Hitachi made hardware and software changes to the former Summitcameras and sought FDA clearance for the updates, according toMike Uehara, president of Hitachi Medical Corp. of America inTarrytown, NY. The single-head camera will be marketed as SpectraDigital150DS while the dual-head will receive the product name SpectraDigital260DS.

The new variable-angle dual-head system has been named SpectraDigitalV250DSP. The camera employs an analog-to-digital converter oneach photomultiplier tube and uses digital signal processors fordecoding, according to Uehara. The older cameras do not use digitalsignal processors.

Hitachi is tentatively planning to display the cameras at theSociety of Nuclear Medicine meeting in June and has reserved boothspace at the conference. The company will make a final decisionin March on whether to attend, Uehara said.

In other Hitachi product clearance news, the FDA gave the nodto the company's unique rotational angiography system, SF-VA100.Rather than using a more traditional C-arm configuration, thesystem's x-ray tube is located in a gantry that spins around thepatient. SF-VA100 could be an alternative to biplane angiographyrooms. Fourteen systems have been installed in Japan.