MULTIX Impact; MULTIX Impact C— 510(k) K260488
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K260488 for MULTIX Impact; MULTIX Impact C, Substantially Equivalent on 2026-08-31. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Summary
Siemens Medical Solutions USA filed MULTIX Impact and MULTIX Impact C together under product code KPR, stationary x-ray systems. The record doesn't say how the two names differ.
Class II, 21 CFR 892.1680. Radiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Siemens filed from Malvern, Pennsylvania. The substantially equivalent decision came 199 calendar days after receipt (February 13 to August 31, 2026).
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Product code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code KPR
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.