510(k) K852284

DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA by Digirad Corp. — Product Code LLZ

K852284 is an FDA 510(k) premarket notification submitted by Digirad Corp. for the device "DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA". The FDA issued a decision of Substantially Equivalent on November 14, 1985. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Digirad Corp. has at least 10 other 510(k) clearances on record.