# K260488: MULTIX Impact; MULTIX Impact C

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 31, 2026 after 199 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: 16 generations back to K801623 (1980). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213700: MULTIX Impact, MULTIX Impact C, Siemens Medical Solutions USA, Inc. (2021) Summary page 6.

## 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. MULTIX Impact C is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact C 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 C is not intended for mammography. MULTIX Impact C uses digital detectors for generating diagnostic images by converting X-rays into image signals. MULTIX Impact C is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

Source page: https://510kreport.com/device/K260488
Methodology: https://510kreport.com/methodology