510(k) K260488

MULTIX Impact; MULTIX Impact C by Siemens Medical Solutions USA, Inc. — Product Code KPR

K260488 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "MULTIX Impact; MULTIX Impact C". The FDA issued a decision of Substantially Equivalent on August 31, 2026. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2026
Date Received
February 13, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type