510(k) K243473

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS by Prognosys Medical Systems Private Limited — Product Code IZL

K243473 is an FDA 510(k) premarket notification submitted by Prognosys Medical Systems Private Limited for the device "PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS". The FDA issued a decision of Substantially Equivalent on July 29, 2025. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Prognosys Medical Systems Private Limited has at least 2 other 510(k) clearances on record.