510(k) K183474

Carestream DRX-1 System with DRX Core Detectors by Carestream Health, Inc. — Product Code MQB

K183474 is an FDA 510(k) premarket notification submitted by Carestream Health, Inc. for the device "Carestream DRX-1 System with DRX Core Detectors". The FDA issued a decision of Substantially Equivalent on January 16, 2019. 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.