Reference

Innokas Medical helped Athlos get FDA clearance for its Bluetooth®, direct conversion intraoral sensor

Project timeline:
months
Service areas:
Quality and Regulatory
Written by
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DC-Air™ is an intraoral x-ray imaging sensor designed, developed, and manufactured by a Finnish company Athlos. The solution is used to produce high-quality imaging in dental practices.

In July 2021, the sensor passed the FDA 510(k) clearance and is now legally permitted to be marketed in the US. Innokas Medical’s quality and regulations specialist worked together with the Athlos team to handle the complex and burdensome process to manage, collect, and file the 510(k) submission to the FDA.

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