510(k) K221405

Neurophet SCALE PET by Neurophet., Inc. — Product Code LLZ

K221405 is an FDA 510(k) premarket notification submitted by Neurophet., Inc. for the device "Neurophet SCALE PET". The FDA issued a decision of Substantially Equivalent on Aug 5, 2022. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Neurophet., Inc. has at least 5 other 510(k) clearances on record.