510(k) K920724

HIGH SPEED ROTATION STARTER SA-50 by Shimadzu Medical Systems — Product Code ITY

K920724 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "HIGH SPEED ROTATION STARTER SA-50". The FDA issued a decision of Substantially Equivalent on April 27, 1992. The device falls under product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1760. Shimadzu Medical Systems has at least 10 other 510(k) clearances on record.