510(k) K212080

Imaging Plate Scanner, i-Scan by Guilin Woodpecker Medical Instrument Co., Ltd. — Product Code MUH

K212080 is an FDA 510(k) premarket notification submitted by Guilin Woodpecker Medical Instrument Co., Ltd. for the device "Imaging Plate Scanner, i-Scan". The FDA issued a decision of Substantially Equivalent on September 27, 2021. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Guilin Woodpecker Medical Instrument Co., Ltd. has at least 10 other 510(k) clearances on record.