510(k) K243077

Affirm 800 by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) — Product Code IZI

K243077 is an FDA 510(k) premarket notification submitted by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) for the device "Affirm 800". The FDA issued a decision of Substantially Equivalent on June 27, 2025. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) has at least 1 other 510(k) clearance on record.