# K193089: MULTIX Impact

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 20, 2020 after 135 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: 13 generations back to K801623 (1980). 69 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182517: MULTIX Impact, Siemens Medi Cal Solutions, Inc. (2019) Summary page 5.

## Most influential descendants
- K203345: MULTIX Impact (2021), 5 descendants of its own
- K203340: MULTIX Impact C (2021), 3 descendants of its own
- 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

## Indications for use
The MULTIX Impact system 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. The MULTIX Impact system is not meant for mammography. The MULTIX Impact uses digital detectors for generating diagnostic images by converting X-rays into image signals. The MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

Source page: https://510kreport.com/device/K193089
Methodology: https://510kreport.com/methodology