NeuroLogica Corporation announced that Chinese FDA has approved its life saving CereTom portable CT Scanner. The approval paves way for company’s expansion into the Chinese medical device market. The company announced that it will establish a business connection office in Beijing.
The CereTom is a portable eight slice CT scanner can be used MICU, SICU, ICU, NICU, ER, OR, interventional suite, or any medical clinic. It is compact and lightweight that is 74 cm (29 inches) deep, five feet (153 cm) tall and four feet (134 cm) wide and weighs approximately 341kg (750 pounds). It is being used by top medical centers and hospitals around the world.
We are extremely pleased with the cooperative effort among various Chinese State agencies, and especially the FDA, in granting approval of our Portable CT scanner for the Chinese market, said Dr. Eric Bailey, President & CEO of NeuroLogica Corporation. We believe the performance and convenience of our portable CT scanner will make a positive contribution to the quality of health care throughout China.
The CereTom Portable CT scanner got Chinese FDA approval after proving several key Chinese standards. That includes safety testing by an independent Chinese testing laboratory, review of scanner’s history of performance. Apart from this company’s design and manufacturing systems had to demonstrate compliance with the rigorous ISO 13485 International Quality System Requirements for Medical Devices and the US Food & Drug Administration Quality System Regulations. All these reviews are completed by the Chinese government agencies.