510(k) K042361

DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D by Sedecal USA, Inc. — Product Code IZL

K042361 is an FDA 510(k) premarket notification submitted by Sedecal USA, Inc. for the device "DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D". The FDA issued a decision of Substantially Equivalent on September 29, 2004. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Sedecal USA, Inc. has at least 2 other 510(k) clearances on record.