# K231577: MOBILETT Impact

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions
- Decided: Jul 25, 2023 after 55 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K896095 (1990). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222951: SM-V, Sedecal., Sa. (2022) Summary page 5.

## Indications for use
MOBILETT Impact is a mobile device intended to visualize anatomical structures of human beings by converting an X-ray pattern into a visible image. MOBILETT Impact is not intended for mammography examinations.

Source page: https://510kreport.com/device/K231577
Methodology: https://510kreport.com/methodology