# K220919: MULTIX Impact E

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 17, 2022 after 48 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K801623 (1980). 71 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203345: MULTIX Impact, Siemens Medical Solutions USA, Inc. (2021) Summary page 5.

## Most influential descendants
- K242499: Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (2025), 0 descendants of its own
- K233532: MULTIX Impact E (2023), 0 descendants of its own

## Indications for use
MULTIX Impact E is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact E enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and obese patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact E is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. MULTIX Impact E is not intended for mammography.

Source page: https://510kreport.com/device/K220919
Methodology: https://510kreport.com/methodology