510(k) K042383

RSA-CMS by Medis Medical Imaging Systems BV — Product Code LLZ

K042383 is an FDA 510(k) premarket notification submitted by Medis Medical Imaging Systems BV for the device "RSA-CMS". The FDA issued a decision of Substantially Equivalent on October 20, 2004. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Medis Medical Imaging Systems BV has at least 10 other 510(k) clearances on record.