510(k) K213307

Eclipse II with Smart Noise Cancellation by Carestream Health, Inc. — Product Code MQB

K213307 is an FDA 510(k) premarket notification submitted by Carestream Health, Inc. for the device "Eclipse II with Smart Noise Cancellation". The FDA issued a decision of Substantially Equivalent on January 14, 2022. 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.