# K222951: SM-V

- Pathway: 510(k) (Abbreviated)
- Applicant: Sedecal., Sa.
- Decided: Nov 21, 2022 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: 11 generations back to K896095 (1990). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212291: Phoenix, Sedecal., Sa. (2021) Summary page 4.

## Most influential descendants
- K231577: MOBILETT Impact (2023), 0 descendants of its own

## Indications for use
This is a mobile diagnostic x-ray system intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

Source page: https://510kreport.com/device/K222951
Methodology: https://510kreport.com/methodology