Casio Computer Co., Ltd. has announced the successful FDA registration of its medical cameras designed for uterocervical observation and photography in gynecological settings. Additionally, the cameras have received approval from the Australian Therapeutic Goods Administration (TGA).
The DZ-C100 COLPOCAMERA and CST-100M camera stand, accompanied by the D’z IMAGE Viewer C software, are now available in the United States, Australia, and New Zealand. These cameras were initially released in Japan in March 2022, where they garnered positive feedback for their support in the early detection of cervical cancer.
The DZ-C100 COLPOCAMERA is equipped with unique imaging capabilities, allowing it to capture normal, green, and polarized images with a single press of the shutter. Furthermore, when attached to the CST-100M camera stand, it offers smooth maneuverability to obtain the desired observation position.
Both the DZ-C100 and the CST-100M have been registered as Class II medical devices by the FDA and as Class I medical devices by the TGA. They have also been registered in New Zealand’s Web Assisted Notification of Devices (WAND) Database. Casio America, Inc. is responsible for distributing these products in the United States, while C.R. KENNEDY & Company Pty. Ltd handles distribution in Australia and New Zealand.
The expansion of Casio’s COLPOCAMERA to the United States, Australia, and New Zealand positions the company as a global contributor to the medical field. Through their high-definition imaging and user-friendly Touch Focus Function, these cameras promise to aid medical professionals in accurate diagnosis and treatment.
As Casio continues to grow its medical device business, its commitment to improving healthcare worldwide remains unwavering. The FDA registration and TGA approval mark significant milestones in Casio’s journey to revolutionize gynecological observation and photography.
FAQs on Casio’s FDA Registered Medical Cameras for Uterocervical Observation and Photography
1. What are the key features of Casio’s medical cameras for uterocervical observation and photography?
Casio’s medical cameras, including the DZ-C100 COLPOCAMERA and CST-100M camera stand, offer unique imaging capabilities. The DZ-C100 can capture normal, green, and polarized images with a single press of the shutter. When attached to the CST-100M camera stand, it provides smooth maneuverability for optimal observation positioning.
2. Where are these medical cameras available?
These cameras are now available in the United States, Australia, and New Zealand. They were initially released in Japan in March 2022 and received positive feedback for their support in detecting cervical cancer.
3. What are the regulatory approvals for these cameras?
The DZ-C100 and the CST-100M have been registered as Class II medical devices by the FDA and as Class I medical devices by the Australian Therapeutic Goods Administration (TGA). They have also been registered in New Zealand’s Web Assisted Notification of Devices (WAND) Database.
4. How are these cameras distributed in different regions?
Casio America, Inc. is responsible for distributing these cameras in the United States. C.R. KENNEDY & Company Pty. Ltd handles distribution in Australia and New Zealand.
5. What benefits do these cameras offer to medical professionals?
Casio’s medical cameras promise to aid medical professionals in accurate diagnosis and treatment. Their high-definition imaging and user-friendly Touch Focus Function enhance the observation and photography process.
Key Terms:
– Uterocervical observation: Refers to the examination and observation of the cervix and uterus.
– FDA: The Food and Drug Administration, a regulatory agency in the United States responsible for ensuring the safety and efficacy of medical devices.
– Australian Therapeutic Goods Administration (TGA): Regulatory body in Australia responsible for regulating therapeutic goods, including medical devices.
– Class II medical devices: Classification of medical devices by the FDA that require special controls for their use and higher levels of assurance of safety and effectiveness.
– Class I medical devices: Classification of medical devices that are considered low-risk and do not require the same level of regulatory control as higher-risk devices.
Related Links:
– Casio Official Website
– FDA Official Website
– TGA Official Website