510(k) K254013

SubtleHD-PET (1.x) by Subtle Medical, Inc. — Product Code LLZ

K254013 is an FDA 510(k) premarket notification submitted by Subtle Medical, Inc. for the device "SubtleHD-PET (1.x)". The FDA issued a decision of Substantially Equivalent on May 14, 2026. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Subtle Medical, Inc. has at least 10 other 510(k) clearances on record.