FDA Registration Completed in the United States and TGA Approval Obtained in Australia
TOKYO, March 12, 2024 /PRNewswire/ — Casio Computer Co., Ltd. announced today that the DZ-C100 COLPOCAMERA, which is designed for uterocervical observation and photography in gynecological settings, and the CST-100M camera stand are released in the US, Australia and New Zealand today. The image management software D’z IMAGE Viewer C is also available in both regions.
CST-100M(with DZ-C100 attached)
In March 2022 in Japan, Casio released the DZ-C100 COLPOCAMERA, which supports the early detection of cervical cancer, and the CST-100M camera stand, which is designed for ease of operability and convenience.
The camera can capture three types of images (normal, green, polarized) with a single press of the shutter. Not only that, when attached to the stand, it can be moved smoothly to the desired observation position and fixed there. Casio began providing these products in Europe in September 2023, and the DZ-C100 has been well-received by medical professionals in the region, who appreciate its high-definition images and the Touch Focus Function, which makes it easy to focus the images shown on the LCD monitor.
Registration of the DZ-C100 and the CST-100M as Class II medical devices by the U.S. Food and Drug Administration (FDA) has been completed. They have also been approved as Class I medical devices by the Australian Therapeutic Goods Administration (TGA). They also have been registered in the Web Assisted Notification of Devices (WAND) Database in New Zealand. The products are sold by Casio America, Inc., a sales subsidiary in the U.S., and by distributor C.R. KENNEDY & Company Pty. Ltd in Australia and New Zealand.
Now expanding the reach of COLPOCAMERA to the U.S., Australia and New Zealand, Casio continues to grow its medical device business, contributing to the medical field around the world.
Available for purchase through the following Casio site:https://www.casio.com/us/medical-devices/product.DZ-C100/?from=202403prnewswire(United States)
D’z IMAGE Viewer C
DZ-C100
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