510(k) K192894

Vita Flex CR System with LLI by Carestream Health, Inc. — Product Code MQB

K192894 is an FDA 510(k) premarket notification submitted by Carestream Health, Inc. for the device "Vita Flex CR System with LLI". The FDA issued a decision of Substantially Equivalent on February 18, 2020. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Carestream Health, Inc. has at least 10 other 510(k) clearances on record.