11/1/2004
For Immediate Release
HITACHI MEDICAL SYSTEMS AMERICA, INC. ANNOUNCES FDA 510(K) CLEARANCE OF THE SCEPTRE P3 PET/CT SYSTEM
CONTACT:
Raymond Wtulich
Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, Ohio 44087
800.800.3106 or 330.425.1313 Ext. 2616
330.425.1410 Fax
info@hitachimed.com
www.hitachimed.com
Hitachi Medical Systems America has received FDA 510(k) clearance to market its new Sceptre P3 PET/CT system in the United States. HMSA previewed the Sceptre P3 at the 2004 Society of Nuclear Medicine (SNM) meeting held in mid-June in Philadelphia, Pennsylvania
Sceptre P3 integrates the “Power of Three” suite of differentiating capabilities. Dual Attenuation Correction (DAC Technology) allows the combination of both CT and sealed source attenuation correction to effectively image patients with metal implants and prosthetics. The only FDA cleared Non-Rigid Fusion7D algorithm provides precise registration by correcting for respiration differences between PET and CT acquisitions. And the integration of the AVIA-PACS architecture improves operational communication, multi-modal connectivity and scalable RAID archiving capabilities.
“The Sceptre P3 is the result of an effort to address a number of clinical challenges that exist today with PET/CT, including imaging implant patients, correcting for respiration artifacts and providing PACS connectivity,” stated Raymond Wtulich, Marketing Product Manager for HMSA’s PET division. “We have introduced solutions supported by the benefits of fast LSO PET and the proven reliability of the Hitachi CT platform.”
The Sceptre P3 also brings to the market a unique patient comfort design that includes an illuminated patient bore and vented airflow; features that were initiated from the result of feedback from community based healthcare forums. In addition, the Sceptre P3 has been designed with field upgrade capability. “The Evolve program was presented at the recent Society of Nuclear Medicine Meeting and allows Sceptre dedicated PET customers an opportunity to cost effectively upgrade to the benefits of PET/CT,” Wtulich remarks.
For more information on the new SceptreP3 PET/CT, please visit www.sceptreP3.com