# K203345: MULTIX Impact

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 7, 2021 after 55 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: 14 generations back to K801623 (1980). 70 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193089: MULTIX Impact, Siemens Medical Solutions USA, Inc. (2020) Summary page 5.

## Most influential descendants
- K220919: MULTIX Impact E (2022), 2 descendants of its own
- K213700: MULTIX Impact, MULTIX Impact C (2021), 2 descendants of its own
- K260488: MULTIX Impact; MULTIX Impact C (2026), 0 descendants of its own
- 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 is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact is not intended for mammography. MULTIX Impact uses digital detectors for generating diagnostic images by converting X-rays into image signals. MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

Source page: https://510kreport.com/device/K203345
Methodology: https://510kreport.com/methodology