510(k) K170786

Faxitron Bioptics Speciemen Radiography System by Faxitron Bioptics, LLC — Product Code MWP

K170786 is an FDA 510(k) premarket notification submitted by Faxitron Bioptics, LLC for the device "Faxitron Bioptics Speciemen Radiography System". The FDA issued a decision of Substantially Equivalent on July 18, 2017. The device falls under product code MWP (Cabinet, X-Ray System), a Class II device regulated under 21 CFR 892.1680. Faxitron Bioptics, LLC has at least 4 other 510(k) clearances on record.